NCT06073847 A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
| NCT ID | NCT06073847 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bristol-Myers Squibb |
| Condition | Primary Myelofibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 137 participants |
| Start Date | 2023-06-13 |
| Primary Completion | 2027-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 137 participants in total. It began in 2023-06-13 with a primary completion date of 2027-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT06073847 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Primary Myelofibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06073847 currently recruiting?
Yes, NCT06073847 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT06073847 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06073847 clinical trial?
NCT06073847 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 137 participants.