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A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
Sponsor: Bristol-Myers Squibb
Summary
The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review \& Assessment Service.
Official title: Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
OBSERVATIONAL
Enrollment
137
Start Date
2023-06-13
Completion Date
2027-12-20
Last Updated
2024-11-06
Healthy Volunteers
No
Conditions
Interventions
Fedratinib
According to the approved label
Locations (3)
Bristol-Myers Squibb YH
Seoul, South Korea
Local Institution - 0001
Seoul, South Korea
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea