Managed Access Program for Momelotinib in Myelofibrosis

• Conditions: Myelofibrosis; Primary 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

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08

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