NCT00907478

Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP)

A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate changes in bone marrow morphology (structure) after long-term exposure to romiplostim.

Detailed description

Participants diagnosed with ITP according to the American Society of Hematology (ASH) Guidelines were sequentially enrolled into the following groups: * Bone marrow biopsy at Baseline and Year 1 * Bone marrow biopsy at Baseline and Year 2 * Bone marrow biopsy at Baseline and Year 3. All participants received romiplostim for 3 years, unless withdrawn from the study early. Participants returned for one visit for End of Study (EOS) procedures 4 weeks after romiplostim discontinuation, or, for participants who were withdrawn from the study due to the presence of collagen fibrosis, or had a change to grade 3 reticulin, at 12 weeks after discontinuation of romiplostim.

Conditions

• Thrombocytopenia
• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
BIOLOGICAL	romiplostim	Romiplostim administered by subcutaneous injection

Timeline

• Start date: 2009-08-11
• Primary completion: 2014-01-09
• Completion: 2014-01-14
• First posted: 2009-05-22
• Last updated: 2022-09-21
• Results posted: 2015-01-01