NCT04054921

Safety Study for Beta Thalassemia Subjects on PTG-300

An Open Label Extension Study of PTG-300 In Non-Transfusion Depenent (NTD) and Trasfusion-Dependent (TD) B-Thalassemia Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Protagonist Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In this study will investigate long term safety and use of the PTG-300 in Beta Thalassemia patients.

Detailed description

The PTG-300-03 study will study beta thalassemia patients on PTG-300 for two years. The dose and dose frequency for each subject enrolling in the PTG-300-03 study will be based on the last dose and frequency received by the subject in the previous study PTG-300-02 and the subject's response at that dose. Patients dose will be increased in a manner similar to that used on PTG-300-02 study. The maximum PTG-300 dose allowed is 80 mg/week.

Conditions

• β-thalassemia
• Ineffective Erythropoiesis

Interventions

Type	Name	Description
DRUG	PTG-300	PTG-300 is a hepcidin Mimetic

Timeline

• Start date: 2019-05-10
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2019-08-13
• Last updated: 2021-07-16

Locations

16 sites across 8 countries: United States, Greece, Lebanon, Malaysia, Thailand, Tunisia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study