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

Expanded Access (Compassionate Use) of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory Immune Thrombocytopenic Purpura (ITP)

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

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

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.