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Trial Title:
A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia
NCT ID:
NCT06073860
Condition:
Myelodysplastic Syndrome
Beta Thalassemia
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Thalassemia
beta-Thalassemia
Syndrome
Luspatercept
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Luspatercept
Description:
According to the approved label
Arm group label:
Participants with myelodysplastic syndrome or beta thalassemia who will begin luspatercept treatment
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.
Criteria for eligibility:
Study pop:
Adults with transfusion-dependent anemia associated with very low, low, and
intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or
MDS/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)
who had an unsatisfactory response to, or are ineligible for erythropoietin-based
therapy, and adults with transfusion-dependent anemia associated with beta thalassemia,
who will begin therapy with luspatercept.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Local Institution - 0001
Address:
City:
Seoul
Zip:
06234
Country:
Korea, Republic of
Status:
Terminated
Facility:
Name:
Novotech Laboratory Korea Co., Ltd.
Address:
City:
Seoul
Zip:
06234
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
South Korea Generic Country, Site 0002
Phone:
0000000000
Start date:
March 25, 2024
Completion date:
December 21, 2027
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073860
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
