Clinical Trials Logo
  1. Home
  2. Thrombocytopenia
  3. NCT00415532

Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura

Thrombocytopenia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00415532
Study type Interventional
Source Amgen
Contact
Status Completed
Phase Phase 3
Start date December 1, 2006
Completion date May 11, 2009
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04003220 - Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Recruiting NCT03633019 - High-dose Use of rhTPO in CIT Patients Phase 4
Recruiting NCT06087198 - Clinical Performance Evaluation of T-TAS®01 HD Chip
Recruiting NCT03605511 - TTP and aHUS in Complicated Pregnancies
Active, not recruiting NCT03688191 - Study of Sirolimus in CTD-TP in China Phase 4
Completed NCT02845609 - Efficacy of Sialic Acid GNE Related Thrombocytopenia Phase 2
Recruiting NCT02244658 - Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia Phase 3
Recruiting NCT02241031 - Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia Phase 2/Phase 3
Completed NCT01356576 - Effect of Hemodialysis Membranes on Platelet Count N/A
Unknown status NCT01196884 - Immune Thrombocytopenia (ITP) Immune-Genetic Assessment
Terminated NCT01368211 - Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study) Phase 2/Phase 3
Completed NCT00039858 - Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin Phase 4
Completed NCT00787241 - Platelet Count Trends in Pre-eclamptic Parturients N/A
Completed NCT00001533 - Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine Phase 1
Not yet recruiting NCT06036966 - The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients Phase 2
Completed NCT01791101 - Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia. Phase 2
Recruiting NCT06053021 - Antiplatelet Therapy for AIS Patients With Thrombocytopenia N/A
Recruiting NCT03701217 - Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML Phase 2/Phase 3
Not yet recruiting NCT05958511 - Assessment of Risk Factors and Outcome of Thrombocytopenia in ICU Patients