A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia

Launched by BRISTOL-MYERS SQUIBB · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the safety of a medication called luspatercept for Korean patients who have myelodysplastic syndrome (MDS) or beta thalassemia, which are conditions that affect how blood cells are made. The study is observational, meaning researchers will monitor the participants who are starting treatment with luspatercept to see how well they tolerate it in a real-world setting.

To be eligible for this study, participants need to be adults aged 19 or older and must be starting luspatercept treatment as approved in South Korea. They also need to provide their consent to participate. Participants can expect to share their experiences with the medication, and their safety will be closely monitored throughout the study. This trial is important because it will help gather information about how luspatercept works in everyday patients and ensure it is safe for those with these specific blood disorders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult participants 19 years of age or older
• • Participants who will be treated with luspatercept according to the approved label in the Republic of Korea
• • Participants who sign the informed consent form
• Exclusion Criteria:
• • Participants who are prescribed luspatercept for therapeutic indications not approved in the Republic of Korea
• • Participants for whom luspatercept is contraindicated as clarified in the Korean prescribing information approved by the Ministry of Food and Drug Safety