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

Last updated: November 5, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia (Pediatric)

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Treatment

Fedratinib

Clinical Study ID

NCT06073847
CA054-005
  • Ages > 19
  • All Genders

Study 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), 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

Inclusion

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 havereceived or are receiving fedratinib will also be registered

  • Participants who signed the informed consent form

Exclusion

Exclusion Criteria:

  • Participants who have been prescribed fedratinib for an indication not approved inKorea

  • Participants who have been prescribed fedratinib at a dose not approved in Korea

  • Participants for whom fedratinib is contraindicated as clarified in Koreanprescribing information approved by the Ministry of Food and Drug Safety

Study Design

Total Participants: 137
Treatment Group(s): 1
Primary Treatment: Fedratinib
Phase:
Study Start date:
June 13, 2023
Estimated Completion Date:
December 20, 2027

Connect with a study center

  • Bristol-Myers Squibb YH

    Seoul, 06178
    Korea, Republic of

    Active - Recruiting

  • Local Institution - 0001

    Seoul, 06234
    Korea, Republic of

    Terminated

  • Novotech Laboratory Korea Co., Ltd.

    Seoul, 06234
    Korea, Republic of

    Active - Recruiting

  • PPC Korea Co.,Ltd

    Seoul, 06234
    Korea, Republic of

    Active - Recruiting

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