NCT01143038

Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim

A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.

Detailed description

The study includes a 4-week screening period, a 12-month romiplostim treatment period, and a romiplostim dose-tapering period. During the 12-month treatment period romiplostim doses could be increased or decreased to maintain a platelet count between ≥ 50 x 10\^9/L and ≤ 200 x 10\^9/L. Participants who dose reduce such that they no longer require treatment with romiplostim during the 12-month treatment period will continue with all required study procedures up to 12 months and will be monitored for ITP remission for at least 6 months. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L will enter the tapering period, during which the romiplostim dose will be decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. If a participant maintains a platelet count of ≥ 50 x 10\^9/L in the absence of romiplostim and all medications for ITP (concomitant or rescue), the participant will be followed for at least 6 months to confirm the incidence of ITP remission. If a participant's platelet count falls below 50 x 10\^9/L and the participant has tapered off treatment with romiplostim, the participant will enter the stabilization period and reinitiate romiplostim for up to 8 weeks.

Conditions

• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
BIOLOGICAL	Romiplostim	Romiplostim will be administered weekly by subcutaneous injection

Timeline

• Start date: 2010-11-30
• Primary completion: 2013-09-20
• Completion: 2013-12-26
• First posted: 2010-06-14
• Last updated: 2022-09-21
• Results posted: 2016-02-24

Locations

48 sites across 9 countries: United States, Australia, Czechia, France, Germany, Italy, Poland, Spain, United Kingdom