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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06073847
• Collaborator: (none)
• Enrollment: 137
• Location: 1
• Anticipated Duration (Months): 74.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis	Drug: Fedratinib

Study Design

• Study Type: Observational
• Anticipated Enrollment: 137 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
• Actual Study Start Date: Jul 13, 2023
• Anticipated Primary Completion Date: Jan 31, 2028
• Anticipated Study Completion Date: Sep 27, 2029

Arms and Interventions

Arm	Intervention/Treatment
Participants with myelofibrosis receiving fedratinib	Drug: Fedratinib; According to the approved label

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bristol-Myers Squibb YH	Seoul		Korea, Republic of	06178

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT06073847
• Other Study ID Numbers: CA054-005
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential

Study Results

No Results Posted as of Oct 10, 2023