A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia
- Registration Number
- NCT06073860
- Lead Sponsor
- Bristol-Myers Squibb
- 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 participants who will begin treatment with at least 1 dose of luspatercept.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 104
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with myelodysplastic syndrome or beta thalassemia who will begin luspatercept treatment Luspatercept -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Local Institution - 0001
🇰🇷Seoul, Korea, Republic of
Novotech Laboratory Korea Co., Ltd.
🇰🇷Seoul, Korea, Republic of