Status:
NO_LONGER_AVAILABLE
Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP
Lead Sponsor:
Rigel Pharmaceuticals
Conditions:
Immune Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- Adult patient with chronic or persistent ITP.
- Must have failed or are unable to receive standard of care treatments for ITP.
- Must have at least two platelet counts \< 30,000/µL during the last 2 months prior to screen date.
Exclusion
- ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
- Subject has uncontrolled or poorly controlled hypertension.
- 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.
- Active HBV or HCV infection.
- Current or recent enrollment in an investigational drug or device study.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03363334
Last Update
August 1 2018
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