Trials / Completed
CompletedNCT00415532
Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura
A Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 234 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of romiplostim. After the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month Safety Follow-up period.
Conditions
- Idiopathic Thrombocytopenic Purpura
- Thrombocytopenia
- Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
- Thrombocytopenic Purpura
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Medical Standard of Care for ITP | |
| BIOLOGICAL | Romiplostim |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2008-11-07
- Completion
- 2009-05-11
- First posted
- 2006-12-25
- Last updated
- 2022-11-08
- Results posted
- 2013-07-08
Source: ClinicalTrials.gov record NCT00415532. Inclusion in this directory is not an endorsement.