Status:
RECRUITING
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Primary Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Eligibility:
All Genders
19+ years
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), ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 20 2027
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT06073847
Start Date
June 13 2023
End Date
December 20 2027
Last Update
November 6 2024
Active Locations (3)
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1
Bristol-Myers Squibb YH
Seoul, South Korea, 06178
2
Local Institution - 0001
Seoul, South Korea, 06234
3
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea, 06234