Status:
COMPLETED
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
Lead Sponsor:
CSL Behring
Conditions:
Primary Immunodeficiency (PID)
Eligibility:
All Genders
2-65 years
Phase:
PHASE3
Brief Summary
This study is a continuation of the study ZLB06\_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID...
Eligibility Criteria
Inclusion
- Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common variable immunodeficiency (CVID) as defined by the Pan-American Group for Immunodeficiency (PAGID) and the European Society for Immunodeficiencies (ESID), or X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or autosomal recessive agammaglobulinemia who have participated in the study ZLB06\_001CR and who have tolerated IgPro well
- Written informed consent
Exclusion
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as total urine protein concentration \> 0.2g/L)
- Other significant medical conditions that could increase the risk to the subject
- Females who are pregnant, breast feeding or planning a pregnancy during the course of the study
- Participation in a study with an investigational medicinal product within three months prior to enrollment, except for ZLB06\_001CR
- Evidence of uncooperative attitude
- Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study
- Subjects who are employees at the investigational site, relatives or spouse of the investigator
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00751621
Start Date
August 1 2008
End Date
December 1 2011
Last Update
April 2 2014
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Study Site
Paris, France, 75743
2
Study Site
Berlin, Germany, 13353
3
Study Site
Freiburg im Breisgau, Germany, 79095
4
Study Site
Leipzig, Germany, 04129