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

Rigel Pharmaceuticals

Status

Conditions: Immune Thrombocytopenic Purpura

Treatments: Drug: Fostamatinib disodium 150 mg; Drug: Fostamatinib disodium 100 mg

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03363334

C-935788-055

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.