CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 407 enrolled
Drug / intervention
Romiplostimbiological
Likely dose
Romiplostim 5.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00508820
NCT00508820Phase 3Completed
CompareCT.gov

An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Amgen·interventional·Posted Jul 30, 2007·Updated Nov 14, 2022

In Brief

A Phase 3 clinical trial evaluating Romiplostim for Idiopathic Thrombocytopenic Purpura and 2 related conditions. Completed, enrolled 407 participants.

Detailed Summary

This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are \> 50,000.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenic Purpura
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 30, 2007
Enrollment StartFeb 1, 2005
Primary CompletionJan 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 18.9 years ago

Interventions

Romiplostimbiological

Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.