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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00515203 |
The purpose of this study is to evaluate the safety and tolerability of AMG 531 in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also evaluate the efficacy of AMG 531 and characterize the pharmacokinetics of AMG 531. It is anticipated that AMG 531, when given at an effective dose and schedule, will be well tolerated treatment for thrombocytopenia among pediatric subjects with chronic ITP.
Condition | Intervention | Phase |
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Idiopathic Thrombocytopenic Purpura Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) |
Drug: AMG 531 Drug: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Study to Determine the Safety and Efficacy of AMG 531 in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura |
Enrollment: | 22 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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II.: Placebo Comparator
5 thrombocytopenic (as defined per protocol) subjects
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Drug: Placebo
Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.
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I.: Experimental
15 thrombocytopenic (as defined per protocol) subjects
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Drug: AMG 531
Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.
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Ages Eligible for Study: | 12 Months to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Research Site | |
Little Rock, Arkansas, United States | |
United States, California | |
Research Site | |
San Diego, California, United States | |
Research Site | |
Orange, California, United States | |
United States, Massachusetts | |
Research Site | |
Boston, Massachusetts, United States | |
United States, Michigan | |
Research Site | |
Detroit, Michigan, United States | |
United States, Nebraska | |
Research Site | |
Omaha, Nebraska, United States | |
United States, New York | |
Research Site | |
New York, New York, United States | |
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States | |
United States, South Carolina | |
Research Site | |
Charleston, South Carolina, United States | |
United States, Tennessee | |
Research Site | |
Memphis, Tennessee, United States | |
Research Site | |
Nashville, Tennessee, United States | |
United States, Texas | |
Research Site | |
Houston, Texas, United States | |
Research Site | |
Dallas, Texas, United States | |
Australia | |
Research Site | |
Herston, Australia | |
Canada, Ontario | |
Research Site | |
Ottawa, Ontario, Canada | |
Spain | |
Research Site | |
Barcelona, Spain |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060195 |
Study First Received: | August 9, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00515203 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Australia: Therapeutic Goods Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Spain: Agencia Española de Medicamentos y Productos Sanitarios; United States: Food and Drug Administration; United States: Institutional Review Board |
Immune (Idiopathic) Thrombocytopenic Purpura Pediatric Idiopathic Thrombocytopenic Purpura |
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 |