Study of PTG-300 in Non-Transfusion Dependent and Transfusion-Dependent Beta-Thalassemia Subjects With Chronic Anemia — TRANSCEND  

ß-thalassemia Clinical Trial

Official title: A Phase 2 Study of PTG-300 in Non-Transfusion Dependent (NTD) and Transfusion-Dependent (TD) β-Thalassemia Subjects With Chronic Anemia

Status Completed

Clinical Trial Summary

This is a Phase 2 open-label, single-arm design study with dose escalation by subject cohort . The study is designed to monitor the PTG-300 safety profile, to obtain preliminary evidence of efficacy of PTG-300 for the treatment in β-thalassemia.

Clinical Trial Description

This is a Phase 2 open-label, single-arm design study with dose escalation by subject cohort and with the potential for individual titration (dose increase or decrease) within each cohort. The study is designed to monitor the PTG-300 safety profile, to obtain preliminary evidence of efficacy of PTG-300 for the treatment of chronic anemia in β-thalassemia and to evaluate the appropriate dosing regimen for PTG-300 in the target population ;

Related Conditions & MeSH terms

• Anemia
• beta-Thalassemia
• Chronic Anemia
• Ineffective Erythropoiesis
• ß-thalassemia
• Thalassemia

• NCT number: NCT03802201
• Study type: Interventional
• Source: Protagonist Therapeutics, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: December 19, 2018
• Completion date: July 31, 2020