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

NCT06073847 | Recruiting FDA Drug

• 1 other identifier: CA054-005
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 3

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.

Conditions

Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

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

  Up to 6 months

Study Arms (1)

Participants with myelofibrosis receiving fedratinib

Drug: Fedratinib

Interventions

Fedratinib DRUG

According to the approved label

Participants with myelofibrosis receiving fedratinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who were previously treated with ruxolitinib

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Bristol-Myers Squibb YH

Seoul, 06178, South Korea

RECRUITING

Local Institution - 0001

Seoul, 06234, South Korea

TERMINATED

Novotech Laboratory Korea Co., Ltd.

Seoul, 06234, South Korea

RECRUITING

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

fedratinib

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: June 13, 2023
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)