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Sponsored by: |
CSL Behring |
Information provided by: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT00419341 |
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgG with Proline (IgPro) in subjects with PID. The study should evaluate whether the rate of clinically documented serious bacterial infections (SBIs) per subject per year is less than 1.The primary objective of the pharmacokinetic (PK) substudy is to show that the chosen SC dose regimen is associated with steady-state AUCs not inferior to those obtained with the previous IV dose regimen. Secondary objectives of the PK substudy are to determine the PK parameters AUC, Cmax and Tmax of total IgG, and the serum concentration of IgG subclasses, specific IgGs and L-proline.
Condition | Intervention | Phase |
Primary Immunodeficiency (PID) |
Drug: IgG with Proline (IgPro) |
Phase III |
ChemIDplus related topics: | Globulin, Immune Immunoglobulins Proline |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), (IgG With Proline - IgPro) in Subjects With Primary Immunodeficiency (PID) |
Estimated Enrollment: | 50 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 2 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CSL Behring ( Christian Peters / MD, PhD ) |
Study ID Numbers: | ZLB04_009CR |
First Received: | December 22, 2006 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00419341 |
Health Authority: | United States: Food and Drug Administration |
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