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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 SyndromeBeta-Thalassemia

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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