RecruitingNCT06073860

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

Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia

Sponsor

Bristol-Myers Squibb

Enrollment

104 participants

Start Date

Mar 25, 2024

Study Type

OBSERVATIONAL

Conditions

Myelodysplastic Syndrome

Summary

The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.

Eligibility

Min Age: 19 Years

Inclusion Criteria3

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 Criteria2

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

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Interventions

DRUGLuspatercept

According to the approved label

Locations(2)

Local Institution - 0001

Seoul, South Korea

Novotech Laboratory Korea Co., Ltd.

Seoul, South Korea

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NCT06073860

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