Actively Recruiting
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
Led by Bristol-Myers Squibb · Updated on 2024-11-06
137
Participants Needed
3
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Bristol-Myers Squibb YH
Seoul, South Korea, 06178
Actively Recruiting
2
Local Institution - 0001
Seoul, South Korea, 06234
Terminated
3
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea, 06234
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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