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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)

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03363334
Enrollment
Unknown
Registered
2017-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenic Purpura

Keywords

ITP, Immune Thrombocytopenia

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.

Interventions

DRUGFostamatinib disodium 100 mg

Fostamatinib Disodium tablet 100 mg PO bid (morning and evening)

DRUGFostamatinib disodium 150 mg

Fostamatinib Disodium tablet 150 mg PO bid (morning and evening)

Sponsors

Rigel Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026