Individual Patient Compassionate Use of Fedratinib
- Conditions
- Myelofibrosis
- Registration Number
- NCT03723148
- Lead Sponsor
- Celgene
- Brief Summary
This is an expanded access program (EAP) for eligible participants designed to provide access to fedratinib.
Expanded access is only available in markets where fedratinib is not yet approved.
- Detailed Description
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as a participant on a clinical trial prior to 31 Jan 2018.
Exclusion Criteria
Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has been treated with Fedratinib after 31 Jan 2018.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celgene
🇺🇸Summit, New Jersey, United States