Trials / Completed
CompletedNCT02773290
Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia
Phase 2/3 Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Refractory to or Ineligible for Immunosuppressive Therapy
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Romiplostim | Weekly SC administration |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2017-11-14
- Completion
- 2020-07-28
- First posted
- 2016-05-16
- Last updated
- 2024-07-16
Locations
3 sites across 2 countries: Japan, South Korea
Source: ClinicalTrials.gov record NCT02773290. Inclusion in this directory is not an endorsement.