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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00111475 |
The purposes of this study are: to determine a weekly dose that demonstrates a satisfactory safety profile and sustains elevated platelet counts within a targeted therapeutic level (a doubling of baseline platelet counts and within the range of greater than or equal to 50 x 10^9/L and less than or equal to 450 x 10^9/L in thrombocytopenic subjects with ITP; to assess Amgen megakaryopoiesis protein 2 [AMP2 (AMG 531)] pharmacokinetics (PK) in thrombocytopenic subjects with ITP.
Condition | Intervention | Phase |
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Idiopathic Thrombocytopenic Purpura |
Drug: AMG 531 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Official Title: | A Dose-Finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment - Have completed at least 1 prior treatment for ITP - The mean of the 2 platelet counts taken during the screening and pre-treatment periods must be: *less than 30 x 10^9/L for those subjects not receiving any ITP therapy, with no count greater than 35 x 10^9/L; less than 50 x 10^9/L for those subjects receiving a constant dose schedule of corticosteroids, with no count greater than 55 x 10^9/L - Hemoglobin greater than 10.0 g/dL - Written informed consent Exclusion Criteria: - Any known history of bone marrow stem cell disorder - Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization - Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [New York Heart Association (NYHA) greater than class II], uncontrolled hypertension [diastolic greater than 100 mmHg] or cardiac arrhythmia) - Have 3 or more of the following predisposing factors for thromboembolic events: *diabetes; *smoker using oral contraceptives; *hypercholesteremia (greater than 240 mg/dL); *treatment for hypertension - Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus - Received any treatment for ITP (except for a constant dose schedule of corticosteroids) within 4 weeks before the screening visit - Received IVIg or WinRho within 2 weeks before the screening visit - Received hematopoietic growth factors, including IL-11 (Neumega®) within 4 weeks before the screening visit - Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO) or related platelet product - Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study - Received any monoclonal antibody (eg, rituximab) within 16 weeks before the screening visit or anticipated use during the time of the proposed study - Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication before the screening period - Less than 2 months since major surgery (including laparoscopic splenectomy) - Pregnant or breast feeding - Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20000137 |
Study First Received: | May 20, 2005 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00111475 |
Health Authority: | United States: Food and Drug Administration |
Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura Thrombocytopenic Thrombocytopenia ITP |
Purpura Autoimmune Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemostatic Disorders Purpura, Thrombocytopenic |
Signs and Symptoms Thrombocytopathy Thrombocytopenia Hemorrhagic Disorders Thrombocytopenic purpura, autoimmune Purpura, Thrombocytopenic, Idiopathic |
Skin Manifestations Immune System Diseases |