Managed Access Program for Momelotinib in Myelofibrosis

GlaxoSmithKline (GSK)

Status

Conditions: Myelofibrosis; Primary Myelofibrosis

Treatments: Drug: Momelotinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05582083

219595

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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