Status:
ACTIVE_NOT_RECRUITING
A Real-World Study of β-Thalassemia Major Treatment With Luspatercept in Taiwan
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
β-Thalassemia Major
Eligibility:
All Genders
18+ years
Brief Summary
This real-world study will assess the efficacy and safety of luspatercept treatment for β-thalassemia major in Taiwan as well as the impact on quality of life.
Eligibility Criteria
Inclusion
- Participants ≥18 years of age.
- Participants with the diagnosis of transfusion-dependent β-thalassemia major who are eligible to the treatment of luspatercept.
- Before luspatercept treatment, participant's transfusion burden ≥ 24 Red Blood Cell units in 24 weeks, without ≥35-day transfusion free.
Exclusion
- Hypersensitivity to the active substance or to any of the excipients.
- Pregnancy.
- Participants requiring treatment to control the growth of extramedullary hematopoiesis (EMH) masses.
Key Trial Info
Start Date :
August 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 17 2026
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06596642
Start Date
August 21 2024
End Date
December 17 2026
Last Update
June 4 2025
Active Locations (5)
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1
Local Institution - 02
Kaohsiung City, Taiwan, 807
2
Local Institution - 04
Tainan, Taiwan, 704
3
Local Institution - 01
Taipei, Taiwan, 100229
4
Local Institution - 03
Taipei, Taiwan, 10449