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

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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Key information

Conditions

Primary Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Post-essential Thrombocythemia Myelofibrosis Post-polycythemia Vera Myelofibrosis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bristol-Myers Squibb YH, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fedratinib

Drug

According to the approved label

Primary outcomes

Number of participants with adverse events

Time frame: Up to 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Oct 10, 2023
Registry last updated: Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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