A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
Recruiting
Observational Study
Primary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia Myelofibrosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Study type
Observational
Participants needed
137 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for
This trial is looking for adults with myelofibrosis who have not responded well to or cannot tolerate another treatment called ruxolitinib. Participants will take a medication called fedratinib and help researchers understand its safety in real-world use.
Are You a Good Fit for This Trial?
Must be takingRuxolitinib
You may be able to join if
I am 19 years old or older
I will receive fedratinib as approved in Korea
I have signed the informed consent form
You may not be able to join if
I have been prescribed fedratinib for a condition not approved in Korea
I have been prescribed fedratinib at a dose not approved in Korea
Fedratinib is contraindicated for me according to Korean guidelines
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Facility
City
State
Country
Status
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 sig…
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
Contacts
BMS Study Connect Contact Center www.BMSStudyConnect.com
First line of the email MUST contain NCT # and Site #.
CONTACT
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