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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06073860

Enrollment

104

Registered

2023-10-10

Start date

2024-03-25

Completion date

2027-12-21

Last updated

2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta Thalassemia, Myelodysplastic Syndrome

Brief 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.

Interventions

DRUGLuspatercept

According to the approved label

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events (AEs)	Up to 6 months

Countries

South Korea

Contacts

Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com

Clinical.Trials@bms.com855-907-3286

Backup ContactFirst line of the email MUST contain NCT # and Site #.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026