Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP (NCT03363334) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP
Plain-language summary
C-935788-055 is an open-label, multi-center, expanded access (EAP) study.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.