Back to resultsExpanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP
Primary Purpose
Immune Thrombocytopenic Purpura
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Fostamatinib disodium 100 mg
Fostamatinib disodium 150 mg
Sponsored by
About this trial
This is an expanded access trial for Immune Thrombocytopenic Purpura focused on measuring ITP, Immune Thrombocytopenia
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03363334
Brief Title
Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP
Official Title
Expanded Access (Compassionate Use) of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory Immune Thrombocytopenic Purpura (ITP)
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura
Keywords
ITP, Immune Thrombocytopenia
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fostamatinib disodium 100 mg
Other Intervention Name(s)
Fostamatinib, R935788, R788
Intervention Description
Fostamatinib Disodium tablet 100 mg PO bid (morning and evening)
Intervention Type
Drug
Intervention Name(s)
Fostamatinib disodium 150 mg
Other Intervention Name(s)
Fostamatinib, R935788, R788
Intervention Description
Fostamatinib Disodium tablet 150 mg PO bid (morning and evening)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Duliege, M.D.
Organizational Affiliation
Rigel Pharmaceuticals, Inc., Chief Medical Officer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP
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