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| Sponsor: | CSL Behring |
|---|---|
| Information provided by: | CSL Behring |
| ClinicalTrials.gov Identifier: | NCT00322556 |
Purpose
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency |
Drug: Immunoglobulins Intravenous (Human) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID) |
| Enrollment: | 44 |
| Study Start Date: | November 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 4 Years to 71 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contacts and Locations| United States, California | |
| Contact CSL Behring for facility details | |
| Los Angeles, California, United States, 90027 | |
| United States, Colorado | |
| Contact CSL Behring for facility details | |
| Centennial, Colorado, United States, 80112 | |
| United States, Florida | |
| Contact CSL Behring for facility details | |
| North Palm Beach, Florida, United States, 33408 | |
| Contact CSL Behring for facility details | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Indiana | |
| Contact CSL Behring for facility details | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Contact CSL Behring for facility details | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Minnesota | |
| Contact CSL Behring for facility details | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Contact CSL Behring for facility details | |
| St. Louis, Missouri, United States, 63104-1095 | |
| United States, Texas | |
| Contact CSL Behring for facility details | |
| Dallas, Texas, United States, 75230 | |
More Information
| Responsible Party: | Global Head Clinical Research & Development, CSL Behring |
| ClinicalTrials.gov Identifier: | NCT00322556 History of Changes |
| Other Study ID Numbers: | ZLB05_006CR |
| Study First Received: | May 5, 2006 |
| Last Updated: | February 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Immunoglobulin Intravenous Agammaglobulinemia Hypogammaglobulinemia |
Common variable immunodeficiency Immunoglobulin G Children |
|
Agammaglobulinemia Common Variable Immunodeficiency Immunologic Deficiency Syndromes IgG Deficiency Blood Protein Disorders Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immune System Diseases |
Dysgammaglobulinemia Immunoglobulins Antibodies Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |