- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00405184
Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
June 5, 2012 updated by: CSL Limited
A Multi-centre, Open-label, Cross-over Study to Compare the Pharmacokinetics, Safety and Tolerability of Ig NextGen 10% With Intragam P in Patients With Primary Immune Deficiency (PID)
This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals.
Patients will be monitored on the study for up to 36 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 3
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
-
-
South Australia
-
Adelaide, South Australia, Australia
- Flinders Medical Centre
-
Adelaide, South Australia, Australia
- Royal Adelaide Hospital
-
-
Victoria
-
Melbourne, Victoria, Australia
- The Alfred Hospital
-
Melbourne, Victoria, Australia
- The Royal Melbourne Hospital
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of PID
- = or >6 month use of Intragam P at three- or four-weekly intervals
- = or >6 month history of IgG trough levels of ≥ 5 g/L
Exclusion Criteria:
- Newly diagnosed PID within six months prior to Screening
- Known selective IgA deficiency or antibodies to IgA
- Immunosuppressive treatment other than topical and/ or inhaled steroids and/ or low dose oral steroids
- Protein-losing enteropathies, or kidney diseases
- History of malignancies of lymphoid cells
- Any of the following laboratory results at Screening:
- Serum Creatinine > 1.5 times the upper normal limit (UNL)
- AST or ALT concentration > 2.5 times the UNL
- Albumin < 25 g/L
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)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
IgG Trough Pharmacokinetics
Time Frame: one month
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability, Pharmacokinetics
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karl Bleasel, Dr, Melbourne Health
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.
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
May 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
November 27, 2006
First Submitted That Met QC Criteria
November 27, 2006
First Posted (Estimate)
November 29, 2006
Study Record Updates
Last Update Posted (Estimate)
June 7, 2012
Last Update Submitted That Met QC Criteria
June 5, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSLCT-PID-05-22
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.
Clinical Trials on Primary Immune Deficiency (PID)
-
University Hospital, Strasbourg, FranceCompletedPrimary Immune-Deficiency (PID) Common Variable Immune Deficiency (CVID)France
-
ShireCompleted
-
CSL BehringCompletedPrimary Immunodeficiency (PID)Poland, Germany, France, Romania, Spain, Sweden, Switzerland, United Kingdom
-
TakedaTakeda Development Center Americas, Inc.Not yet recruitingPrimary Immunodeficiency Diseases (PID)
-
Baxalta now part of ShireCompletedPrimary Immunodeficiency Diseases (PID)Japan
-
Baxalta now part of ShireBaxalta Innovations GmbH, now part of ShireCompletedPrimary Immunodeficiency Diseases (PID)Denmark, United Kingdom, Czechia, France, Greece, Hungary, Slovakia, Sweden
-
Baxalta now part of ShireCompleted
-
Baxalta now part of ShireCompletedPrimary Immunodeficiency Diseases (PID)United States
-
Baxalta now part of ShireBaxalta Innovations GmbH, now part of ShireCompletedPrimary Immunodeficiency Diseases (PID)Canada
-
TakedaActive, not recruitingPrimary Immunodeficiency Diseases (PID)Japan