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NCT05582083 Clinical Trial

Managed Access Program for Momelotinib in Myelofibrosis

Myelofibrosis Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT05582083
Other study ID # 219595
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date November 2023
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Momelotinib
Momelitinib available as tablets.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline
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