Trials / Recruiting
RecruitingNCT06073847
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 137 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fedratinib | According to the approved label |
Timeline
- Start date
- 2023-06-13
- Primary completion
- 2027-12-20
- Completion
- 2027-12-20
- First posted
- 2023-10-10
- Last updated
- 2024-11-06
Locations
3 sites across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06073847. Inclusion in this directory is not an endorsement.