Myelodysplastic Syndrome Clinical Trial
Official title:
Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta 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.
| Status | Recruiting |
| Enrollment | 104 |
| Est. completion date | September 27, 2029 |
| Est. primary completion date | December 30, 2028 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Bristol-Myers Squibb YH | Seoul | |
| Korea, Republic of | PPC Korea Co.,Ltd | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) | Up to 6 months |
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