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Trial Title:
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
NCT ID:
NCT06073847
Condition:
Primary Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Conditions: Official terms:
Polycythemia Vera
Primary Myelofibrosis
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Fedratinib
Description:
According to the approved label
Arm group label:
Participants with myelofibrosis receiving fedratinib
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.
Criteria for eligibility:
Study pop:
Adult participants with primary myelofibrosis, post-polycythemia vera myelofibrosis, or
post-essential thrombocythemia myelofibrosis who were previously treated with ruxolitinib
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bristol-Myers Squibb YH
Address:
City:
Seoul
Zip:
06178
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ji-Hyun Kim
Phone:
+82-3404-1300
Email:
Ji-hyun.kim@bms.com
Facility:
Name:
Local Institution - 0001
Address:
City:
Seoul
Zip:
06234
Country:
Korea, Republic of
Status:
Terminated
Facility:
Name:
Novotech Laboratory Korea Co., Ltd.
Address:
City:
Seoul
Zip:
06234
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
South Korea Generic Country, Site 0002
Phone:
0000000000
Start date:
June 13, 2023
Completion date:
December 20, 2027
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073847
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
