Clinical Trial: Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase 2/3 Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Refractory to or Ineligible for Immunosuppressive Therapy
Brief Summary:
The objective of this study is to evaluate the efficacy of romiplostim administered once weekly to Aplastic Anemia (AA) patients with thrombocytopenia refractory to or ineligible for immunosuppressive therapy in Japan and Korea.
Safety and pharmacokinetics of romiplostim after repeated administration will also be assessed.
Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd
Current Primary Outcome: Proportion of subjects achieving a hematological response (any of the platelet response, erythroid response, and neutrophil response) at Week 27 [ Time Frame: At 27 weeks after dosing ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of subjects with a hematological response at the end-of- treatment examination [ Time Frame: Up to 52 weeks after dosing ]
- Time from the first romiplostim administration to hematological response [ Time Frame: Up to 52 weeks after dosing ]
- In subjects receiving platelet transfusion as a pretreatment within 8 weeks prior to the first romiplostim administration; proportion of subjects with transfusion independence or decreased platelet transfusion requirement [ Time Frame: Up to 52 weeks after dosing ]
- Proportion of subjects achieving platelet response, erythroid response, or neutrophil response at each of Week 27 and end of treatment. [ Time Frame: At 27 weeks and 52 weeks after dosing ]
Original Secondary Outcome: Same as current
Information By: Kyowa Hakko Kirin Co., Ltd
Dates:
Date Received: May 9, 2016
Date Started: May 2016
Date Completion: December 2020
Last Updated: May 16, 2017
Last Verified: May 2017
