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A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis

Recruitingn/aAges 19 Years - anyAllBristol-Myers Squibb
NCT06073847 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participants 19 years of age or older * Participants who will receive fedratinib according to the approved label * For the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered * Participants who signed the informed consent form Exclusion Criteria: * Participants who have been prescribed fedratinib for an indication not approved in Korea * Participants who have been prescribed fedratinib at a dose not approved in Korea * Participants for whom fedratinib is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
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What it tests

  • Fedratinib
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Where

3 sites
Bristol-Myers Squibb YH
Seoul, South Korea
Local Institution - 0001
Seoul, South Korea
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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