A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Luspatercept.
- Who it may be relevant to
- Registry conditions: Myelodysplastic Syndrome, Beta Thalassemia. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia
Overview
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.
Interventions
- Drug Luspatercept
According to the approved label
Primary outcome measures
- Number of participants with adverse events (AEs) [Time frame: Up to 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
South Korea · 2 centers
- Local Institution - 0001 — Seoul
- Novotech Laboratory Korea Co., Ltd. — Seoul
Identifiers
NCT: NCT06073860 · CA056-005