Status:
RECRUITING
A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Myelodysplastic Syndrome
Beta Thalassemia
Eligibility:
All Genders
19+ years
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 par...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 21 2027
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06073860
Start Date
March 25 2024
End Date
December 21 2027
Last Update
November 6 2024
Active Locations (2)
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1
Local Institution - 0001
Seoul, South Korea, 06234
2
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea, 06234