A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
Recruiting now
Conditions studied: Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
In brief
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.
Key facts
- Study ID
- NCT06073847
- Run by
- Bristol-Myers Squibb
- People needed
- 137
- Starts
- 2023-06-13
- Expected to finish
- 2027-12-20
- Last updated by the study team
- 2024-11-06
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Bristol-Myers Squibb YH — Seoul, South Korea (enrolling)
- Novotech Laboratory Korea Co., Ltd. — Seoul, South Korea (enrolling)
- Local Institution - 0001 — Seoul, South Korea
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.