A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fedratinib.
- Who it may be relevant to
- Registry conditions: Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
Overview
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.
Interventions
- Drug Fedratinib
According to the approved label
Primary outcome measures
- Number of participants with adverse events [Time frame: Up to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 3 centers
- Bristol-Myers Squibb YH — Seoul
- Local Institution - 0001 — Seoul
- Novotech Laboratory Korea Co., Ltd. — Seoul
Identifiers
NCT: NCT06073847 · CA054-005