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

Rigel Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Immune Thrombocytopenic Purpura

Treatments: Drug: Fostamatinib disodium; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02076399

C-935788-047

2013-005452-15 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups

Fostamatinib Disodium

Experimental group

Description:

Subjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability.

Treatment:

Drug: Fostamatinib disodium

Placebo

Other group

Description:

Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Treatment:

Drug: Placebo