Trials / Completed
CompletedNCT00303472
Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)
An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romiplostim |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2008-05-01
- Completion
- 2008-05-01
- First posted
- 2006-03-17
- Last updated
- 2013-12-16
- Results posted
- 2010-11-19
Source: ClinicalTrials.gov record NCT00303472. Inclusion in this directory is not an endorsement.