drugset / Trial / NCT05462548

The Safety and Efficiency of Luspatercept in Chinese Adults With Transfusion Dependent β-thalassemia: a Real-world Study

NCT05462548

Phase 4 Unknown 20 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single-arm, open-label study. Twenty adult patients with transfusion-dependent β -thalassemia will be enrolled to receive Luspatercept with optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice. The main objective of this study was to evaluate the efficacy and safety of Luspatercept in the treatment of adult patients with transfusion-dependent β -thalassaemia in Chinese clinical practice, and to provide evidence reference for subsequent clinical use.

Timeline

Start
2022-07
Primary completion
2023-02-28
Completion
2023-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Luspatercept Protein / enzyme biologic 1 mg/kg Subcutaneous
Subject Luspatercept Protein / enzyme biologic 1.25 mg/kg Subcutaneous