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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

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03802201
Study type Interventional
Source Protagonist Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date December 19, 2018
Completion date July 31, 2020
View Details
See also
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Recruiting NCT05864170 - the Safety and Efficacy Evaluation of HGI-001 Injection in Patients With Transfusion-Dependent β-Thalassemia Early Phase 1
Completed NCT04054921 - Safety Study for Beta Thalassemia Subjects on PTG-300 Phase 2
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Recruiting NCT05494333 - Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia