Overview

A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Status:
Completed
Trial end date:
2016-04-21
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rigel Pharmaceuticals
Criteria
Inclusion Criteria:

- Clinical diagnosis of persistent/chronic ITP for at least 3 months.

- Average platelet count < 30,000/µL (and none > 35,000 unless as a result of rescue
therapy) from at least 3 qualifying counts

Exclusion Criteria:

- Clinical diagnosis of autoimmune hemolytic anemia

- Uncontrolled or poorly controlled hypertension

- History of coagulopathy including prothrombotic conditions