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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Bristol-Myers Squibb YH
RECRUITING
Seoul
Local Institution - 0001
TERMINATED
Seoul
Novotech Laboratory Korea Co., Ltd.
RECRUITING
Seoul
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2023-06-13
Estimated Completion Date: 2027-12-20
Participants
Target number of participants: 137
Treatments
Participants with myelofibrosis receiving fedratinib
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov