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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBristol-Myers Squibb

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Luspatercept

Treatment groups

104 Participants
are divided into 1 treatment group

Sponsors and collaborators