Last updated: 11/06/2023 06:30:15
Managed Access Program for Momelotinib in Myelofibrosis
GSK study ID
219595
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer available
No longer available
Trial overview
Official title: Managed Access Program for momelotinib in patients with a diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anaemia
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
50
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Myelofibrosis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Expanded Access
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- 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
- Pregnant or breastfeeding female
Inclusion and exclusion criteria
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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Not applicable
Results overview
Not applicable
Recruitment status
No longer available
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable
Additional information about the trial
Not applicable
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