Trials / Completed
CompletedNCT04095936
Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia
A Phase 2/3 Study of AMG531 Combined With Ciclosporin A in Patients With Aplastic Anemia Previously Untreated With Immunosuppressive Therapy
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the hematological responses based on the response assessment criteria defined in this study (the 531-004 response assessment criteria) when AMG531 is subcutaneously (SC)-administered with ciclosporin A (CsA) therapy for 6 months in patients with aplastic anemia (AA) who were previously untreated with immunosuppressive therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romiplostim | Subcutaneous administration of 0 to 20ug/kg for 6 months |
Timeline
- Start date
- 2019-12-03
- Primary completion
- 2021-10-07
- Completion
- 2021-10-29
- First posted
- 2019-09-19
- Last updated
- 2022-05-26
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04095936. Inclusion in this directory is not an endorsement.