CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Romiplostim +1 moredrug
Likely dose
Romiplostim administered by subcutaneous injection (dose to be determined in this dose-finding study)AI-extracted
Key inclusion· 7
  • ✓Confirmed ITP diagnosis per ASH guidelines, at least 3 months prior to enrollment
  • ✓Prior receipt of at least 1 treatment for ITP
  • ✓Platelet count <30 × 10⁹/L (if not on ITP therapy) or <50 × 10⁹/L (if on ITP therapy), documented in 2 of 3 counts during screening/pre-treatment
  • ✓ECOG performance status 0–2
Key exclusion· 15
  • ✕Known history of bone marrow stem cell disorder
  • ✕Active malignancy or prior cancer (except basal cell or cervical in situ) with treatment or active disease within 5 years
  • ✕Arterial thrombosis (stroke, TIA, MI) in previous year
  • ✕Venous thrombosis history with ongoing anticoagulation therapy

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

Search/NCT00111475
NCT00111475Phase 2Completed
CompareCT.gov

A Dose-finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

Amgen·interventional·Posted May 23, 2005·Updated Jan 10, 2020

In Brief

A Phase 2 clinical trial evaluating Romiplostim and Placebo for Idiopathic Thrombocytopenic Purpura. Completed, enrolled 45 participants.

Detailed Summary

The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 23, 2005
Enrollment StartJul 1, 2002
Primary CompletionJun 17, 2004
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 21.1 years ago

Interventions

Romiplostimdrug

Administered by subcutaneous injection

Placebodrug

Administered by subcutaneous injection