ASIS for GAMMAGARD in Primary Immunodeficiency (ASISinPI)
June 22, 2015 updated by: ASIS Corporation
ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle).
Bloodless basically implies longer lasting medicinal effects, and minimal side effects - advantages that reflect the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability.
ASIS device is stabilized on the surface of the skin with negative pressure and emits an electrical current to create a bloodless cavity subdermally.
ASIS device correctly, automatically, and consistently delivers therapeutic agents, yet requiring little skill of a practitioner - providing the steady and safe infusion into subdermal bloodless space of virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel, Insulin, and Fillers, etc.
According to the FDA, "This innovation will have major impact on the healthcare industry."
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
- Drug: Gadolinium For abdomen
- Drug: Gadolinium For abdomen
- Drug: Gadolinium For abdomen
- Drug: Gadolinium For lower back
- Drug: Gadolinium For lower back
- Drug: Gadolinium For lower back
- Drug: Efficacy of Gammagard subcutaneously at Week 12
- Drug: Efficacy of Gammagard subcutaneously at Week 12
- Drug: Efficacy of Gammagard subcutaneously at Week 12
- Drug: Efficacy of Gammagard subcutaneously at Week 12
- Drug: Efficacy of Gammagard subcutaneously at Week 12
- Drug: Efficacy of Gammagard subcutaneously at Week 12
- Drug: Efficacy of Gammagard subcutaneously at Week 12
- Drug: Efficacy of Gammagard subcutaneously at Week 12
- Drug: Efficacy of Gammagard subcutaneously at Week 24
- Drug: Efficacy of Gammagard subcutaneously at Week 24
- Drug: Efficacy of Gammagard subcutaneously at Week 24
- Drug: Efficacy of Gammagard subcutaneously at Week 24
- Drug: Efficacy of Gammagard subcutaneously at Week 24
- Drug: Efficacy of Gammagard subcutaneously at Week 24
- Drug: Efficacy of Gammagard subcutaneously at Week 24
- Drug: Efficacy of Gammagard subcutaneously at Week 24
- Drug: Efficacy of Gammagard subcutaneously at Week 36
- Drug: Efficacy of Gammagard subcutaneously at Week 36
- Drug: Efficacy of Gammagard subcutaneously at Week 36
- Drug: Efficacy of Gammagard subcutaneously at Week 36
- Drug: Efficacy of Gammagard subcutaneously at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 12
- Drug: Efficacy of Gammagard subdermally at Week 12
- Drug: Efficacy of Gammagard subdermally at Week 12
- Drug: Efficacy of Gammagard subdermally at Week 12
- Drug: Efficacy of Gammagard subdermally at Week 12
- Drug: Efficacy of Gammagard subdermally at Week 12
- Drug: Efficacy of Gammagard subdermally at Week 12
- Drug: Efficacy of Gammagard subdermally at Week 12
- Drug: Efficacy of Gammagard subdermally at Week 24
- Drug: Efficacy of Gammagard subdermally at Week 24
- Drug: Efficacy of Gammagard subdermally at Week 24
- Drug: Efficacy of Gammagard subdermally at Week 24
- Drug: Efficacy of Gammagard subdermally at Week 24
- Drug: Efficacy of Gammagard subdermally at Week 24
- Drug: Efficacy of Gammagard subdermally at Week 24
- Drug: Efficacy of Gammagard subdermally at Week 24
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Efficacy of Gammagard subdermally at Week 36
- Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
- Drug: Adverse Reactions of Gammagard subcutaneously at Week 24
- Drug: Adverse Reactions of Gammagard subcutaneously at Week 36
- Drug: Adverse Reactions of Gammagard subdermally at Week 12
- Drug: Adverse Reactions of Gammagard subdermally at Week 24
- Drug: Adverse Reactions of Gammagard subdermally at Week 36
Detailed Description
Aim 1 would require 6 months, to demonstrate ASIS device's consistent performance on 60 subjects with Primary Immunodeficiency (PI), and the particular skin affected by this disease.
30 subjects will receive Gadolinium subcutaneously, and 30 subjects will receive Gadolinium subdermally with ASIS device. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g.
GAMMAGARD) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency (PI), and the particular skin affected by it. Case in point, Primary Immunodeficiency (PI) patients are prone to infection, and tend to have scared skin with less vascularity, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which will be very different from the skin of normal patients, while the Gadolinium subdermally Persistent % may or may not change. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over that of total Persistent % subcutaneously, will be different and very specific for the particular skin affected by Primary Immunodeficiency. However, they are valuable indicators that will help us modify the GAMMAGARD dosage and duration to inject into that "unknown" subdermal space for Aim 2.
Aim 2 would require 12 months, using GAMMAGARD, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over subcutaneously, for the same Primary Immunodeficiency subjects. Of course that Relative Prolongation Ability Score in Aim1 will be valuable, but it isn't absolutely required to start Aim 2, because GAMMAGARD's Pharmacokinetics will be studied anyway, by following Peak and Trough levels of immunoglobulin G.
However, the Pharmacokinetics of subdermally injected GAMMAGARD will be just dependent on GAMMAGARD's diffusion out of that subdermal bloodless space; therefore, if GAMMAGARD getting into the bloodstream becomes so severely inhibited, then we can just change the osmolality of GAMMAGARD in the end. The therapeutic advantages of GAMMAGARD with ASIS device subdermally over subcutaneously will also be studied by comparing the reduction of Validated Acute Serious Bacterial Infections, adverse reactions, and injection site pain.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Westminster, California, United States, 92683
- Automatic Subdermal Injector System, Inc
-
Principal Investigator:
- Hanh Nguyen, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Inclusion Criteria in general and for Gadolinium:
- Main Criteria for Inclusion: Eligible Ages: 12 Years to 65
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: Yes
- Must be outpatient, male or female, of any race, between 18 and 65 years of age.
- Must be able to understand the requirements of the study including maintaining a diary, and sign informed consent.
- Must be in good general health as determined by investigator.
- If female of childbearing potential, must have negative pregnancy test result at screening visit and practice reliable method of contraception
Inclusion Criteria for Primary Immunodeficiency in particular:
- Patients 12 years or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.
Exclusion Criteria:
Exclusion Criteria for Primary Immunodeficiency in particular:
- Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Gadolinium For abdomen
Gadolinium For abdomen Total Persistent % subdermally, For abdomen Total Persistent % subcutaneously, and For abdomen Relative Prolongation Ability Score. Gadolinium Magnevist® (gadopentetate dimeglumine) 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients. |
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients. Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients. Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
Other Names:
Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients.
Other Names:
Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients.
Other Names:
Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .
Other Names:
|
|
EXPERIMENTAL: Gadolinium For lower back
1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients. Gadolinium For lower back Total Persistent % subdermally, For lower back Total Persistent % subcutaneously, and For lower back Relative Prolongation Ability Score. |
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients. Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients. Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
Other Names:
Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients.
Other Names:
Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients.
Other Names:
Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .
Other Names:
|
|
EXPERIMENTAL: subjects (%) of any infections
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
|
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
|
|
EXPERIMENTAL: Annual rate of any infections
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
|
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
|
|
EXPERIMENTAL: subjects (%) with Antibiotic use
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
|
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
|
|
EXPERIMENTAL: Annual rate with Antibiotic use
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
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EXPERIMENTAL: subjects (%) with Days out of work
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
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EXPERIMENTAL: Annual rate with Days out of work
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
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EXPERIMENTAL: (%) with hospitalized infections
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
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EXPERIMENTAL: Annual rate hospitalized infections
Annual rate hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Names:
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Names:
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Names:
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Names:
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EXPERIMENTAL: Adverse Injection Local Reactions
Adverse Injection Local Reactions as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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EXPERIMENTAL: Adverse Reactions Headache
Headache as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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EXPERIMENTAL: Adverse Reactions Fever
Fever as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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EXPERIMENTAL: Adverse Reactions Nausea
Nausea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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EXPERIMENTAL: Adverse Reactions Vomiting
Vomiting as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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EXPERIMENTAL: Adverse Reactions Fatigue
Fatigue as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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EXPERIMENTAL: Adverse Reactions Diarrhea
Diarrhea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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EXPERIMENTAL: Adverse Reactions Asthma
Asthma as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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EXPERIMENTAL: Adverse Reactions Oropharyngeal
Oropharyngeal as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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EXPERIMENTAL: Adverse Reactions Abdominal Pain
Abdominal Pain as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Names:
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative Prolongation Ability Score for Gadolinium subdermally injected
Time Frame: 6 months
|
Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Primary Immunodeficiency.
The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %.
This approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency.
The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, in Primary Immunodeficiency will be very valuable indicators for us to modify the GAMMAGARD dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency
Time Frame: 12 months
|
The therapeutic efficacy of GAMMAGARD, in terms of reduction of Validated Acute Serious Bacterial Infections will be compared, eg.
subjects (%) and Annual rate of any infections, subjects (%) and Annual rate of Antibiotic use, subjects (%) and Annual rate with Days out of work, subjects (%) and Annual rate of hospitalized infections, to demonstrate the advantages of ASIS device subdermally over subcutaneously for GAMMAGARD at Week 12, 24, and 36.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Reactions of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency
Time Frame: 12 months
|
Adverse Reactions of GAMMAGARD, in numbers of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain will be compared, to demonstrate the advantages of ASIS device subdermally over subcutaneously for GAMMAGARD at Week 12, 24, and 36.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hanh Nguyen, MD, AUTOMATIC SUBDERMAL INJECTOR SYSTEM,INC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bonilla FA, Bernstein IL, Khan DA, Ballas ZK, Chinen J, Frank MM, Kobrynski LJ, Levinson AI, Mazer B, Nelson RP Jr, Orange JS, Routes JM, Shearer WT, Sorensen RU; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005 May;94(5 Suppl 1):S1-63. doi: 10.1016/s1081-1206(10)61142-8. No abstract available. Erratum In: Ann Allergy Asthma Immunol. 2006 Mar;96(3):504.
- Paonessa DF, Goldstein JC. Anatomy and physiology of head and neck infections (with emphasis on the fascia of the face and neck). Otolaryngol Clin North Am. 1976 Oct;9(3):561-80. No abstract available.
- Magnevist (gadopentetate dimeglumine) Injection Product Information: http://pharma.bayer.com/scripts/pages/en/products/diagnostic_imaging/index.php
- Botox (onabotulinumtoxinA) Product Information: http://www.botoxcosmetic.com/botox_physician_info/Clinical_Information.aspx http://www.clinicaltrials.gov/ct2/show/NCT01313767?term=Botox+pi&rank=1
- GAMMAGARD LIQUID Comparison of Intravenous and Subcutaneous Administration in Primary Immunodeficiency Diseases (PID): http://www.clinicaltrials.gov/ct2/show/NCT00546871?term=Gammagard+subcutaneous&rank=5
- Daw Z, Padmore R, Neurath D, Cober N, Tokessy M, Desjardins D, Olberg B, Tinmouth A, Giulivi A. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion. 2008 Aug;48(8):1598-601. doi: 10.1111/j.1537-2995.2008.01721.x. Epub 2008 May 2.
- Mignogna MD, Fortuna G, Ruoppo E, Adamo D, Leuci S, Fedele S. Variations in serum hemoglobin, albumin, and electrolytes in patients receiving intravenous immunoglobulin therapy: a real clinical threat? Am J Clin Dermatol. 2007;8(5):291-9. doi: 10.2165/00128071-200708050-00004.
- Kreil TR, Berting A, Kistner O, Kindermann J. West Nile virus and the safety of plasma derivatives: verification of high safety margins, and the validity of predictions based on model virus data. Transfusion. 2003 Aug;43(8):1023-8. doi: 10.1046/j.1537-2995.2003.00496.x.
- Ochs HD, Gupta S, Kiessling P, Nicolay U, Berger M; Subcutaneous IgG Study Group. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006 May;26(3):265-73. doi: 10.1007/s10875-006-9021-7.
- Gardulf A, Nicolay U, Asensio O, Bernatowska E, Bock A, Carvalho BC, Granert C, Haag S, Hernandez D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. doi: 10.1007/s10875-006-9002-x. Epub 2006 Apr 26.
- Orange JS, Hossny EM, Weiler CR, Ballow M, Berger M, Bonilla FA, Buckley R, Chinen J, El-Gamal Y, Mazer BD, Nelson RP Jr, Patel DD, Secord E, Sorensen RU, Wasserman RL, Cunningham-Rundles C; Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol. 2006 Apr;117(4 Suppl):S525-53. doi: 10.1016/j.jaci.2006.01.015. Erratum In: J Allergy Clin Immunol. 2006 Jun;117(6):1483. Dosage error in article text.
- Kahwaji J, Barker E, Pepkowitz S, Klapper E, Villicana R, Peng A, Chang R, Jordan SC, Vo AA. Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients. Clin J Am Soc Nephrol. 2009 Dec;4(12):1993-7. doi: 10.2215/CJN.04540709. Epub 2009 Oct 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (ANTICIPATED)
June 1, 2016
Study Completion (ANTICIPATED)
June 1, 2016
Study Registration Dates
First Submitted
April 11, 2014
First Submitted That Met QC Criteria
April 22, 2014
First Posted (ESTIMATE)
April 25, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
June 24, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCTEB017805
- 1R01EB017805 (OTHER_GRANT: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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