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

Recruiting

• Conditions: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
• Interventions: Drug: Fedratinib

• Registration Number: NCT06073847
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-13
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2027-12-20
• Study Completion: 2027-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with myelofibrosis receiving fedratinib	Fedratinib	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 6 months	The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to Inrebic® (fedratinib)

Trial Locations

Locations (3)

Local Institution - 0001; 🇰🇷 Seoul, Korea, Republic of

Novotech Laboratory Korea Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of

Bristol-Myers Squibb YH; 🇰🇷 Seoul, Korea, Republic of