drugset / Trial / NCT01071954

A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura

NCT01071954

Phase 3 Completed 66 enrolled Amgen
NaSingle-groupOpen-labelSupportive care

Summary

This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic patients with immune (Idiopathic) thrombocytopenia purpura. This study is available to pediatric patients who have completed a previous romiplostim ITP study and meet the eligibility criteria of this study.

Timeline

Start
2009-12-30
Primary completion
2017-01-12
Completion
2017-01-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Romiplostim Peptide 10 ug/kg Subcutaneous