NCT00508820

An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP

An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are \> 50,000.

Conditions

• Idiopathic Thrombocytopenic Purpura
• Thrombocytopenia
• Thrombocytopenic Purpura

Interventions

Type	Name	Description
BIOLOGICAL	Romiplostim	Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.

Timeline

• Start date: 2005-02-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2007-07-30
• Last updated: 2022-11-14
• Results posted: 2012-02-13