Trials / Completed
CompletedNCT02094417
A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia
A Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Finding Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia Subjects With Thrombocytopenia Refractory to Immunosuppressive Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Kyowa Kirin Korea Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The present study will be conducted to evaluate the efficacy and safety of AMG531 and to determine the recommended initial dose of AMG531 on the basis of its efficacy and safety when it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics of this product. Its efficacy and safety during the extension period beyond one year will also be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG531 | Subcutaneous, weekly injection |
Timeline
- Start date
- 2014-04-14
- Primary completion
- 2017-04-24
- Completion
- 2017-11-07
- First posted
- 2014-03-21
- Last updated
- 2024-04-30
- Results posted
- 2021-02-15
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02094417. Inclusion in this directory is not an endorsement.