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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-21

Study Completion Date

2026-12-17

Brief Summary

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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.

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Detailed Description

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Conditions

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β-Thalassemia Major

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Adults participants diagnosed with β-thalassemia major

Luspatercept

Intervention Type DRUG

As per product label

Interventions

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Luspatercept

As per product label

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No