- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168025
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
June 5, 2012 updated by: CSL Behring
A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)
The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.
As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10 are studied.
A part of the patients are participating in a pharmacokinetic substudy.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Phase 3
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
3 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Patients with primary immunodeficiency
- Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months
Key Exclusion Criteria:
- Newly diagnosed PID
- Allergic reactions to immunoglobulins or other blood products
- Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
- Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine
- History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IgPro10
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Annualized rate of acute serious bacterial infections
|
Secondary Outcome Measures
Outcome Measure |
---|
Number of infections
|
Number of days out of work / school due to underlying PID
|
Adverse events temporally associated with study drug infusion
|
Trough levels of total IgG serum concentrations
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.
- Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, Bichler J; IgPro10 in PID study group. Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol. 2009 Jan;29(1):137-44. doi: 10.1007/s10875-008-9231-2. Epub 2008 Sep 24.
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
September 1, 2004
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
June 6, 2012
Last Update Submitted That Met QC Criteria
June 5, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Blood Protein Disorders
- Dysgammaglobulinemia
- Immunologic Deficiency Syndromes
- Primary Immunodeficiency Diseases
- Agammaglobulinemia
- Common Variable Immunodeficiency
- IgG Deficiency
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Immunoglobulins
- Immunoglobulins, Intravenous
Other Study ID Numbers
- ZLB03_002CR
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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