Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Rigel Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Immune Thrombocytopenic Purpura

Treatments: Drug: Fostamatinib Disodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT02077192

2013-005454-30 (EudraCT Number)

C-935788-049

Details and patient eligibility

About

The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response.
• Able and willing to give written informed consent

Exclusion criteria

• Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response
• Poorly controlled hypertension during Study C935788-047 or Study C935788-048
• Significant infection, an acute infection such as influenza, or known inflammatory process

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Fostamatinib Disodium

Experimental group

Description:

Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day

Treatment:

Drug: Fostamatinib Disodium