NCT01071954

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

An Open Label Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP

Interventions

Type	Name	Description
BIOLOGICAL	Romiplostim	Administered by subcutaneous injection once a week.

Timeline

• Start date: 2009-12-30
• Primary completion: 2017-01-12
• Completion: 2017-01-12
• First posted: 2010-02-19
• Last updated: 2020-01-18
• Results posted: 2019-01-29

Locations

31 sites across 4 countries: United States, Australia, Canada, Spain