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| Sponsored by: |
Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00102336 |
Purpose
The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response. This study will also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombocytopenia Idiopathic Thrombocytopenic Purpura |
Biological: AMG 531 Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy |
| Enrollment: | 62 |
| Study Start Date: | April 2005 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
AMG 531: Experimental
Active investigational product
|
Biological: AMG 531
Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
|
| Placebo: Placebo Comparator |
Drug: Placebo
Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The platelet count (calculated from the mean of the 2 counts taken during the screening and pre-treatment periods) must be:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20030212 |
| Study First Received: | January 27, 2005 |
| Last Updated: | May 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00102336 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; EU: CHMP; European Union: European Medicines Agency; France and Sweden: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; France: CCPPRB Central Ethics Committee; France: Ministry of Health; Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research; Netherlands: Medicines Evaluation Board; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Spain: Spanish Agency of Medicines; Spain: Spanish Drug Agency |
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immune (idiopathic) thrombocytopenic purpura pre-splenectomy ITP Thrombopenia |
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Purpura Autoimmune Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemostatic Disorders Purpura, Thrombocytopenic Signs and Symptoms |
Thrombocytopathy Methamphetamine Thrombocytopenia Hemorrhagic Disorders Thrombocytopenic Purpura, Autoimmune Purpura, Thrombocytopenic, Idiopathic Amphetamine |
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Purpura Signs and Symptoms Skin Manifestations Autoimmune Diseases Hemorrhagic Disorders Thrombocytopenia |
Immune System Diseases Hematologic Diseases Blood Platelet Disorders Blood Coagulation Disorders Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic |