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Sponsored by: |
CSL Behring |
Information provided by: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT00751621 |
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.
Condition | Intervention | Phase |
Primary Immunodefficiency (PID) |
Biological: IgG with Proline (IgPro) |
Phase III |
ChemIDplus related topics: | Globulin, Immune Immunoglobulins Proline |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgG With Proline - IgPro in Subjects With Primary Immunodeficiency (IgPro EU Extension Study) |
Estimated Enrollment: | 36 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 4 Years to 67 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CSL Behring ( Brigitte Kuenzle ) |
Study ID Numbers: | 1472, ZLB07_002CR |
First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751621 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Romania: National Medicines Agency; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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