A Real-World Study of β-Thalassemia Major Treatment With Luspatercept in Taiwan

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: β-Thalassemia Major

Treatments: Drug: Luspatercept

Study type: Observational

Funder types: Industry

Identifiers

NCT06596642

CA056-1132

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Hypersensitivity to the active substance or to any of the excipients.
• Pregnancy.
• Participants requiring treatment to control the growth of extramedullary hematopoiesis (EMH) masses.

Trial design

61 participants in 1 patient group

Adults participants diagnosed with β-thalassemia major

Treatment:

Drug: Luspatercept