CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in 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/NCT00515203
NCT00515203Phase 2Completed
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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

Amgen·interventional·Posted Aug 13, 2007·Updated Jul 25, 2014

In Brief

A Phase 2 clinical trial evaluating Placebo and AMG 531 for Idiopathic Thrombocytopenic Purpura and 2 related conditions. Completed, enrolled 22 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Thrombocytopenic Purpura, Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 13, 2007
Enrollment StartJul 1, 2007
Primary CompletionMar 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.9 years ago

Interventions

Placebodrug

Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.

AMG 531drug

Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.