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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

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Detailed Description

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

Conditions

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Immune Thrombocytopenic Purpura

Interventions

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Fostamatinib disodium 100 mg

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

Intervention Type DRUG

Fostamatinib disodium 150 mg

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

Intervention Type DRUG

Other Intervention Names

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Fostamatinib R935788 R788 Fostamatinib R935788 R788

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No