Actively Recruiting
Reblozyl4 (Luspatercept) Post-Marketing Safety Study in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia
Led by Bristol-Myers Squibb · Updated on 2024-11-06
104
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study aims to assess the real-world safety of luspatercept in Korean adults diagnosed with myelodysplastic syndrome (MDS) or beta thalassemia. The research focuses on participants who will start treatment with luspatercept to better understand its safety profile in routine clinical use. Participants will receive luspatercept according to the approved label in the Republic of Korea. The study involves enrolling adults aged 19 years or older who are prescribed luspatercept for approved indications. No experimental treatments or placebos are involved, as this study observes standard clinical practice. During the study, researchers will monitor participants for adverse events up to six months after starting luspatercept. They will collect safety data while participants continue their prescribed treatment. This study helps provide important safety information while participants receive regular medical care under supervision.
CONDITIONS
Brief Title
A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Participants prescribed luspatercept for indications not approved in the Republic of Korea
- Participants for whom luspatercept is contraindicated as per Korean prescribing information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive luspatercept according to the approved label.
Visits scheduled according to routine clinical care
Duration - Up to 6 months
Participants are monitored for safety and adverse events after treatment.
Visits scheduled according to routine clinical care
Trial Site Locations
Total: 2 locations
1
Local Institution - 0001
Seoul, South Korea, 06234
Terminated
2
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea, 06234
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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