Assessing the safety of fedratinib in Korean patients with myelofibrosis
Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
This study is testing the safety of a drug called fedratinib in adults with myelofibrosis who haven't responded well to or can't tolerate another treatment called ruxolitinib.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 137 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | fedratinib, ruxolitinib |
| Locations | 3 sites (Seoul and 2 other locations) |
| Trial ID | NCT06073847 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the real-world safety of fedratinib in adult patients diagnosed with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who have previously been treated with ruxolitinib. Participants will be registered if they have lost adequate response to or are intolerant to ruxolitinib, following specific criteria set by the Ministry of Food and Drug Safety. The study will include patients aged 19 and older who consent to participate and will monitor their safety outcomes over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older with primary myelofibrosis or related conditions who have previously been treated with ruxolitinib.
Not a fit: Patients who have been prescribed fedratinib for unapproved indications or at unapproved doses will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety profile of fedratinib for patients with myelofibrosis who have not responded well to ruxolitinib.
How similar studies have performed: Other studies assessing the safety of treatments for myelofibrosis have shown promising results, but this specific approach with fedratinib in the Korean population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul and 2 other locations
- Bristol-Myers Squibb YH — Seoul, South Korea (Recruiting)
- Local Institution - 0001 — Seoul, South Korea (Terminated)
- Novotech Laboratory Korea Co., Ltd. — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.