CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Romiplostimdrug
Likely dose
Romiplostim administered subcutaneously; dose escalated if platelet count ≤50 x 10⁹/L and not rising, peak count ≤450 x 10⁹/L, and no serious adverse eventsAI-extracted
Key inclusion· 4
  • ✓ITP diagnosis for ≥3 months, regardless of splenectomy status
  • ✓At least 1 prior ITP treatment
  • ✓Platelet count <30×10⁹/L (if off ITP therapy) or <50×10⁹/L (if on corticosteroids) on 2 of 3 pretreatment measurements
  • ✓Able to provide informed consent
Key exclusion· 3
  • ✕Known history of arterial thrombosis
  • ✕Active malignancy
  • ✕Bone marrow stem cell disorder

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

Search/NCT00117143
NCT00117143Phase 2Completed
CompareCT.gov

An Open-label, Unit Dose-finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

Amgen·interventional·Posted Jul 4, 2005·Updated Jun 26, 2023

In Brief

A Phase 2 clinical trial evaluating Romiplostim for Thrombocytopenic Purpura. Completed, enrolled 16 participants.

Detailed Summary

The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocytopenic Purpura
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2005
Enrollment StartDec 2, 2002
Primary CompletionJul 19, 2004
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 21.0 years ago

Interventions

Romiplostimdrug

Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed.