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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-13

Study Completion Date

2027-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with myelofibrosis receiving fedratinib

Fedratinib

Intervention Type DRUG

According to the approved label

Interventions

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Fedratinib

According to the approved label

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No