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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00614523 |
Purpose
The DMC for study 20060198, based on review of interim data, recommended modification of study conduct. The DMC expressed their concern that the potential benefit seen in the reduction of bleeding events did not outweigh the potential risk that transient increases in blast cell counts in the romiplostim arm put subjects at risk for diagnosis of and treatment for AML.
| Condition | Intervention | Phase |
|---|---|---|
|
MDS Myelodysplastic Syndromes Thrombocytopenia |
Drug: Placebo Biological: Romiplostim |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| 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) |
| Enrollment: | 250 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | March 2016 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Romiplostim |
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.
|
| Placebo Comparator: Placebo |
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.
|
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 4 week interim wash-out period, a 24-week placebo controlled extended treatment period, and a 4-week follow-up period followed by an End of Study (EOS) visit. 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.
Eligibility| 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:
(Adequate liver function for patients with a confirmed diagnosis of Gilbert's Disease evidenced by ALT ≤ 3 times the laboratory normal range, and AST ≤ 3 times the laboratory normal range.)
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00614523 History of Changes |
| Other Study ID Numbers: | 20060198 |
| Study First Received: | January 31, 2008 |
| Last Updated: | December 15, 2011 |
| 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: Bundesamt fur Sicherheit im Gesundheitswesen; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Austria: Central Ethics Committee; Austria: Competant 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; Austria: Federal Ministry for Health and Women; Denmark: Danish Medicines Agency; Denmark: Laegemiddelstyrelsen; Denmark: Ministry of Health; 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; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Hungary: National Institute of Pharmacy; Ireland: Irish Medicines Board; Italy: Local Ethics Committees; Italy: 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; Norway: Norwegian Medicines Agency; Poland: Drug Institut; 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; Switzerland: Agency for Therapeutic Products; Switzerland: Local Ethics Committee; Switzerland: Swissmedic (Swiss Agency for Therapeutic Products); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health); United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Western Institutional Review Board |
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MDS Low Risk MDS Intermediate-1 Risk MDS Thrombocytopenia |
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Myelodysplastic Syndromes Preleukemia Thrombocytopenia Bone Marrow Diseases |
Hematologic Diseases Precancerous Conditions Neoplasms Blood Platelet Disorders |