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

Recruiting now

Conditions studied: Myelodysplastic Syndrome, Beta Thalassemia

In brief

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.

Key facts

Study ID

NCT06073860

Run by

Bristol-Myers Squibb

People needed

104

Starts

2024-03-25

Expected to finish

2027-12-21

Last updated by the study team

2024-11-06

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novotech Laboratory Korea Co., Ltd. — Seoul, South Korea (enrolling)
• Local Institution - 0001 — Seoul, South Korea

Full record on ClinicalTrials.gov

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