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Clinical Trials in South Korea / NCT06073847
Recruiting Observational

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

NCT06073847 · tracked via the Priya Life Science South Korea tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2023-06-13
Last updated
2024-11-06

Condition(s) studied

Primary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia Myelofibrosis

Investigational drug(s) / intervention(s)

Fedratinib →

Fedratinib: According to the approved label

Study 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

Sex
ALL
Min age
19 Years
Max age
—
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

Primary outcome measure(s)

  • 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 sites (3)

FacilityCityRegionStatus
Bristol-Myers Squibb YH Seoul South Korea Recruiting
Local Institution - 0001 Seoul South Korea Terminated
Novotech Laboratory Korea Co., Ltd. Seoul South Korea Recruiting

More Bristol-Myers Squibb trials in South Korea

A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) Recruiting
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) Starting soon
Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea Recruiting
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy Recruiting
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea Recruiting

Other trials for the same condition

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) Active, not recruiting
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib Recruiting
P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk Active, not recruiting
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions Active, not recruiting
CINC424A2X01B Rollover Protocol Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06073847 on ClinicalTrials.gov ↗ ← All trials in South Korea