A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBristol-Myers Squibb

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adult participants with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who were previously treated with ruxolitinib

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fedratinib

    Drug

    According to the approved label

Treatment groups

137 Participants
are divided into 1 treatment group
Group A: Participants with myelofibrosis receiving fedratinib1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events

The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to Inrebic® (fedratinib)

Time frame
Up to 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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