CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 313 enrolled
Drug / intervention
Romiplostimbiological
Likely dose
Romiplostim 5 mLfrom record
Key inclusion· 2
  • ✓Must have previously completed a romiplostim ITP study
  • ✓Platelet count ≤50×10^9/L at baseline
Key exclusion· 3
  • ✕Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment in prior romiplostim ITP study
  • ✕Received alkylating agents within 4 weeks before screening or anticipated use during study
  • ✕Currently enrolled in or has not completed 4+ weeks since ending other device or drug trial(s), or receiving other investigational agent(s) besides romiplostim

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00116688
NCT00116688Phase 3Completed
CompareCT.gov

An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Amgen·interventional·Posted Jul 1, 2005·Updated Dec 18, 2013

In Brief

A Phase 3 clinical trial evaluating Romiplostim for Thrombocytopenia and Idiopathic Thrombocytopenic Purpura. Completed, enrolled 313 participants.

Detailed Summary

The purpose of this study is to determine the safety of romiplostim as a long-term treatment in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to romiplostim, and to evaluate changes in patient reported outcomes due to the use of romiplostim. Participants must have previously completed a romiplostim ITP study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocytopenia, Idiopathic Thrombocytopenic Purpura
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2005
Enrollment StartAug 1, 2004
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 21.0 years ago

Interventions

Romiplostimbiological

Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.