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

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.

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Key information

Conditions

Myelodysplastic Syndrome Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Beta Thalassemia Bone Marrow Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Myelodysplastic Syndromes Thalassemia beta-Thalassemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001, Seoul, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Luspatercept

Drug

According to the approved label

Primary outcomes

Number of participants with adverse events (AEs)

Time frame: Up to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Oct 10, 2023
Registry last updated: Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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