Trials / Completed
CompletedNCT00117143
Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
An Open-label, Unit Dose-finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romiplostim | Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed. |
Timeline
- Start date
- 2002-12-02
- Primary completion
- 2004-07-19
- Completion
- 2004-07-19
- First posted
- 2005-07-04
- Last updated
- 2023-06-26
- Results posted
- 2019-12-20
Source: ClinicalTrials.gov record NCT00117143. Inclusion in this directory is not an endorsement.