Managed Access Program for Momelotinib in Myelofibrosis
- Conditions
- MyelofibrosisPrimary Myelofibrosis
- Registration Number
- NCT05582083
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Compassionate use access to Momelotinib/GSK3070785 for eligible participant with diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Written informed consent can be obtained from the patient or legally authorised representative as per local regulations
- Diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anemia
- 18 years or older (at the time consent is obtained)
- The patient is willing to abide by the contraception requirements.
- No known hypersensitivity to momelotinib, its metabolites, or any of the formulation excipients
Exclusion Criteria
- Pregnant or breastfeeding female
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method