Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00515203

Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531) in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of romiplostim (AMG 531). It is anticipated that romiplostim (AMG 531), when given at an effective dose and schedule, will be well tolerated treatment for thrombocytopenia among pediatric subjects with chronic ITP.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Idiopathic Thrombocytopenic Purpura
  • Purpura
  • Purpura, Thrombocytopenic
  • Purpura, Thrombocytopenic, Idiopathic
  • Thrombocytopenia
  • Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
  • Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
  • Thrombocytosis
Clinical Trial Details
NCT number NCT00515203
Study type Interventional
Source Amgen
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2007
Completion date August 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT05220878 - Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP Phase 3
Completed NCT00451594 - High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP Phase 3
Withdrawn NCT01276561 - Single Incision Versus Standard Laparoscopic Splenectomy N/A
Completed NCT01713855 - Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura N/A
Recruiting NCT03465020 - Investigation on a Dynamic Cohort of Italian Patients With Active ITP
Completed NCT00603642 - P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura Phase 3
Completed NCT01143038 - Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim Phase 2
Not yet recruiting NCT04128358 - Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind? N/A
Completed NCT00128882 - Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D Phase 2
Completed NCT01525836 - rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP Phase 3
Completed NCT00888901 - Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag Phase 4
Completed NCT00828750 - Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Phase 3
Completed NCT00475423 - A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura. Phase 2
Completed NCT00625443 - Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003 Phase 2
Completed NCT00454857 - Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) N/A
Completed NCT00102323 - AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy Phase 3
Completed NCT05492409 - Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients Phase 3
Terminated NCT01433978 - A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) Phase 3
Withdrawn NCT01443351 - Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Completed NCT01520909 - Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. Phase 3