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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00117143 |
The purpose of this study is to assess the safety, tolerability, and utility of AMG 531 unit dosing (µg) in thrombocytopenic subjects with ITP.
Condition | Intervention | Phase |
---|---|---|
Thrombocytopenic Purpura |
Drug: AMG 531 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | An Open-Label, Unit Dose-Finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Greater than or equal to 3 months history if ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP - 2 of 3 pretreatment platelet counts that were less than 30 x 10^9/L (if not currently on ITP therapy) or less than 50 x 10^9/L (if currently receiving corticosteroids for ITP therapy) - Ability to give informed consent Exclusion Criteria: - Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010218 |
Study First Received: | June 30, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00117143 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura ITP Thrombocytopenia |
Purpura Thrombocytopathy Signs and Symptoms Thrombocytopenia Hematologic Diseases Blood Platelet Disorders |
Blood Coagulation Disorders Thrombocytopenic purpura, autoimmune Purpura, Thrombocytopenic, Idiopathic Hemostatic Disorders Purpura, Thrombocytopenic |
Skin Manifestations Immune System Diseases |