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Study 12 of 168 for search of: | "Thrombocytopenia" |
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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00614523 |
This is a Phase 2, multicenter, randomized, double blind, placebo controlled study designed to assess the efficacy and safety of romiplostim (formerly, AMG 531) treatment in thrombocytopenic MDS subjects. The study is composed of a 26-week placebo controlled test treatment period (romiplostim versus Placebo), a 2 to 4 week interim wash-out period, a 24-week placebo controlled extended treatment period, and a 4-week follow-up period. During the interim wash-out period, a bone marrow biopsy will be performed in the absence of growth factor to assess changes in the marrow. In the extended treatment period, safety assessments will continue and subjects will be allowed to receive any standard of care treatments for MDS.
Subjects will be followed for survival for an additional 60 months following the End of Study (EOS) visit.
Condition | Intervention | Phase |
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MDS Myelodysplastic Syndromes Thrombocytopenia |
Biological: Romiplostim Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) |
Estimated Enrollment: | 240 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Romiplostim: Experimental |
Biological: Romiplostim
Weekly subcutaneous dosing based on platelet count. Starting dose is at 750mcg, up to a maximum dose of 1000mcg, or reduced to a minimum of 250mcg . Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
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Placebo: Placebo Comparator |
Drug: Placebo
Weekly subcutaneous dosing based on platelet count. Starting dose is at 750mcg, up to a maximum dose of 1000mcg, or reduced to a minimum of 250mcg. Placebo is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The mean of the two platelet counts taken within 4 weeks prior to randomization must be:
Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060198 |
Study First Received: | January 31, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00614523 |
Health Authority: | Austria: Secretariat of Health; Belgium: Directorate general for the protection of Public health: Medicines; Belgium: Directorate-General for Medicinal Products; Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment; 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; Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement; Canada: Health Canada; Canada: Health Products and Food Branch; Canada: Institutional Review Board; Czech Republic: State Institute for Drug Control; Czech Republic: Statni ustav pro kontrolu leciv; Denmark: Central Ethics Committee; Denmark: Danish Medicines Agency; Denmark: Laegemiddelstyrelsen; 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: Bundesamt fur Sicherheit im Gesundheitswesen; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Austria: Central Ethics Committee; Austria: Competant Authority; Austria: Federal Ministry for Health and Women; Denmark: Ministry of Health; Estonia: State Agency of Medicines; EU: CHMP; European Union: European Medicines Agency; France and Sweden: European Medicines Agency; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; France: Afssaps - French Health Products Safety Agency; France: CCPPRB Central Ethics Committee; Hungary: National Institute of Pharmacy; Ireland: Irish Medicines Board; Italy: Local Ethics Committees; Italy: Ministry of Health; Latvia: State Agency of Medicines; Lithuania: Ministry of Health; Lithuania: State Medicines Control Agency of Lithuania; Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research; Netherlands: Medicines Evaluation Board; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Norway: Norwegian Medicines Agency; Poland: Drug Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED); Portugal: National Institute of Pharmacy and Medicines; Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health); Russia: Ministry of Health; Slovakia: Ministry of Health; Slovakia: State Institiute for Drug Control; Slovakia: Štátny ústav pre kontrolu lieciv; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Spain: Spanish Agency of Medicines; Spain: Spanish Drug Agency; Sweden: Central Ethics Committee; Sweden: Lakemedelsverket; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
MDS Low Risk MDS Intermediate-1 Risk MDS Thrombocytopenia |
Myelodysplastic syndromes Thrombocytopathy Methamphetamine Preleukemia Thrombocytopenia Precancerous Conditions |
Hematologic Diseases Blood Platelet Disorders Myelodysplasia Myelodysplastic Syndromes Amphetamine Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease Syndrome |