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Clinical Trials in South Korea / NCT06073860
Recruiting Observational

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

NCT06073860 · tracked via the Priya Life Science South Korea tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2024-03-25
Last updated
2024-11-06

Condition(s) studied

Myelodysplastic SyndromeBeta Thalassemia

Investigational drug(s) / intervention(s)

Luspatercept →

Luspatercept: According to the approved label

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants with adverse events (AEs) — Up to 6 months

Trial sites (2)

FacilityCityRegionStatus
Local Institution - 0001 Seoul South Korea Terminated
Novotech Laboratory Korea Co., Ltd. Seoul South Korea Recruiting

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A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) Active, not recruiting

Other trials for the same condition

A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06073860 on ClinicalTrials.gov ↗ ← All trials in South Korea