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

Launched by BRISTOL-MYERS SQUIBB · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the safety of a medication called fedratinib for treating adults with myelofibrosis, a type of blood cancer. Specifically, it is for patients who have primary myelofibrosis or have myelofibrosis after having other blood conditions. These participants have previously been treated with another medication called ruxolitinib but did not have a good response to it or could not tolerate it. The study aims to gather real-world information about how well fedratinib works and its safety for these patients.

To be eligible for the trial, participants must be at least 19 years old and are currently receiving fedratinib as prescribed in Korea. They need to sign a consent form to participate. The study is open to all genders and is currently recruiting participants. Those who have taken fedratinib for unapproved reasons or at unapproved doses will not be eligible. If you join the trial, you can expect regular monitoring to ensure your safety while taking fedratinib, and your experiences will help improve understanding of this treatment for others in the future.

Gender

ALL

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