Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP

• Conditions: Immune Thrombocytopenic Purpura

• Registration Number: NCT03363334
• Lead Sponsor: Rigel Pharmaceuticals

Brief Summary

C-935788-055 is an open-label, multi-center, expanded access (EAP) study.

Detailed Description

The purpose of the program is to provide Fostamatinib in an Expanded Access setting to subjects who meet the selection criteria.

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult patient with chronic or persistent ITP.
2. Must have failed or are unable to receive standard of care treatments for ITP.
3. Must have at least two platelet counts < 30,000/µL during the last 2 months prior to screen date.

Exclusion Criteria

1. ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
2. Subject has uncontrolled or poorly controlled hypertension.
3. Any of the following laboratory abnormalities: neutrophil count of < 1,500/µL, or transaminase levels (ALT, AST) > 1.5x ULN, total bilirubin > 2.0 mg/dL.
4. Active HBV or HCV infection.
5. Current or recent enrollment in an investigational drug or device study.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified