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NCT03363334 Clinical Trial

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

Immune Thrombocytopenic Purpura Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT03363334
Other study ID # C-935788-055
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date June 2018
Source Rigel Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fostamatinib disodium 100 mg
Fostamatinib Disodium tablet 100 mg PO bid (morning and evening)
• Fostamatinib disodium 150 mg
Fostamatinib Disodium tablet 150 mg PO bid (morning and evening)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rigel Pharmaceuticals
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