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Sponsored by: |
CSL Behring |
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Information provided by: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT00168038 |
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic ITP. The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to > 50 x 10^9/L.
Condition | Intervention | Phase |
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Immune Thrombocytopenic Purpura |
Drug: Immunoglobulin Intravenous (Human) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP) |
Estimated Enrollment: | 60 |
Study Start Date: | December 2004 |
Ages Eligible for Study: | 12 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Study ID Numbers: | ZLB03_003CR |
Study First Received: | September 12, 2005 |
Last Updated: | August 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00168038 |
Health Authority: | Germany: Paul-Ehrlich-Institut; Russia: Pharmacological Committee, Ministry of Health; Ukraine: Ministry of Health; United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: Ministry of Health; Poland: Ministry of Health |
Chronic Immune Thrombocytopenic Purpura Chronic Idiopathic Thrombocytopenic Purpura Werlhofs Disease Autoimmune Thrombocytopenia |
Immunglobulin Intravenous Chronic ITP Platelet count Thrombocytopenia |
Purpura Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemostatic Disorders Purpura, Thrombocytopenic Signs and Symptoms Thrombocytopathy |
Antibodies Thrombocytopenia Immunoglobulins, Intravenous Thrombocytopenic purpura, autoimmune Purpura, Thrombocytopenic, Idiopathic Rho(D) Immune Globulin Immunoglobulins |
Skin Manifestations Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |