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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00415532 |
This is a phase 3b, multi-center, randomized, SOC-controlled, open-label, 52-week treatment study to compare AMG 531 to medical SOC for ITP, with a 6-month Safety Follow-up. Subjects randomized to AMG 531 must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of AMG 531. After the completion or discontinuation of the study treatment period, any subject who does not transfer in to another AMG 531 study will complete a 6-month Safety Follow-up period.
Condition | Intervention | Phase |
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Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura |
Biological: AMG531 Drug: Medical Standard of Care for ITP |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Controlled, Open-Label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-Splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic Purpura |
Estimated Enrollment: | 210 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
AMG 531
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Biological: AMG531
Subcutaneous injection of AMG 531 QW. AMG 531 will be presented as a lyophilized, white powder in 5.0 mL glass vials.
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2
Medical standard of care: Medical standard of care treatments are to be selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines.
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Drug: Medical Standard of Care for ITP
Medical SOC treatments are to be selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines. Medical standard of care treatments will be obtained through the usual commercial routes and will not be provided by Amgen. These drugs will be formulated, packaged, labeled, and stored according to local manufacturer, supplier, and institutional procedures. The investigator will be responsible for obtaining supplies of these medications.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060131 |
Study First Received: | December 21, 2006 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00415532 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Australia: Therapeutic Goods Administration; Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information; Austria: Federal Ministry for Health and Women; Austria: Secretariat of Health; Belgium: Directorate general for the protection of Public health: Medicines; Belgium: FPS of Public Health, Food Chain Security and Environment; Belgium: Pharmaceutical Inspectorate; Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Canada: Health Canada; Canada: Health Products and Food Branch; Czech Republic: State Institute for Drug Control; Czech Republic: Statni ustav pro kontrolu leciv; EU: CHMP; European Union: European Medicines Agency; Switzerland: Agency for Therapeutic Products; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Institutional Review Board; France and Sweden: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Poland: Drug Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Institute of Pharmacy and Medicines; Spain: Spanish Agency of Medicines; Spain: Spanish Drug Agency; Sweden: Medical Products Agency |
splenectomy platelet AMG 531 thrombopoietin blood disorder bleeding disorder |
immune thrombocytopenic purpura idiopathic thrombocytopenic purpura immune (idiopathic) thrombocytopenic purpura TPO thrombopoietic protein |
Purpura Autoimmune Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemorrhage Hemostatic Disorders Purpura, Thrombocytopenic |
Thrombocytopathy Signs and Symptoms Methamphetamine Thrombocytopenia Hemorrhagic Disorders Thrombocytopenic purpura, autoimmune Purpura, Thrombocytopenic, Idiopathic Amphetamine |
Skin Manifestations Immune System Diseases |