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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00603642 |
The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .
Condition | Intervention | Phase |
---|---|---|
Idiopathic Thrombocytopenic Purpura |
Drug: Placebo Drug: AMG 531 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura |
Estimated Enrollment: | 30 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AMG 531: Placebo Comparator
Double blinded placebo-controlled study
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Drug: AMG 531
Subcutaneously administered, once a week, for 12 weeks
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Placebo: Placebo Comparator |
Drug: Placebo
Subcutaneously administered, once a week, for 12 weeks
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
Japan | |
Research Site | Recruiting |
Hirakata, Japan | |
Research Site | Recruiting |
Chuo, Japan | |
Research Site | Recruiting |
Sagamihara, Japan | |
Research Site | Recruiting |
Tokyo, Japan | |
Research Site | Recruiting |
Isehara, Kanagawa, Japan | |
Research Site | Recruiting |
Sapporo, Hokkaido, Japan | |
Research Site | Recruiting |
Kumamoto, Japan | |
Research Site | Recruiting |
Hiroshima, Hiroshima, Japan | |
Research Site | Recruiting |
Suita, Osaka, Japan |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060216 |
Study First Received: | January 17, 2008 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00603642 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
AMG 531 Idiopathic Thrombocytopenic Purpura ITP Thrombocytopenia |
Japan Placebo controlled Phase 3 |
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 |