NCT02076412

A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).

Conditions

• Immune Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	Fostamatinib Disodium	Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
DRUG	Placebo	Placebo tablet PO bid (morning and evening)

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-03-03
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

35 sites across 9 countries: United States, Austria, Bulgaria, Czechia, Germany, Norway, Poland, Romania, Spain