NCT00706342

Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)

A Phase II, Open-Label, Efficacy and Safety, Ascending Dose, Pilot Study of be Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura

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

Summary

The purpose of this study is to determine whether Fostamatinib Disodium is safe and effective in the treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP).

Detailed description

Patients with chronic refractory ITP are eligible for a 6- to 12-week therapeutic trial. After 24 months of treatment, patients who continue to demonstrate a sustained response, in the investigator's judgment, will be offered the opportunity to receive ongoing therapy.

Conditions

• Purpura, Thrombocytopenic, Idiopathic

Interventions

Type	Name	Description
DRUG	Fostamatinib Disodium / R935788	R935788 tablets

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-06-27
• Last updated: 2016-06-03
• Results posted: 2014-08-13

Locations

2 sites across 1 country: United States