NCT06073860 A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia
| NCT ID | NCT06073860 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bristol-Myers Squibb |
| Condition | Myelodysplastic Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 104 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2027-12-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 104 participants in total. It began in 2024-03-25 with a primary completion date of 2027-12-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT06073860 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Myelodysplastic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06073860 currently recruiting?
Yes, NCT06073860 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT06073860 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06073860 clinical trial?
NCT06073860 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 104 participants.