Trials / Completed
CompletedNCT03957694
Study of AMG531(Romiplostim) in Patients With Aplastic Anemia
A Phase 2/3 Study of AMG531 in Patients With Aplastic Anemia PreviouslyUntreated With Immunosuppressive Therapy
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 17 (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 when AMG531 is subcutaneous (SC)-administered with anti-human thymocyte immunoglobulin (ATG) + 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 | Romiplostim SC. Initial dose is 10 ug/kg/. Maximum dose is 20 ug/kg. Original duration is 6 months from first administration but if investigator decide that the patient is needed more treatment, they move to extention period and take treatment up to 1 year. |
Timeline
- Start date
- 2019-04-25
- Primary completion
- 2020-11-05
- Completion
- 2021-05-26
- First posted
- 2019-05-21
- Last updated
- 2022-05-26
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03957694. Inclusion in this directory is not an endorsement.