Summary

Eligibility
for people ages 12-65 (full criteria)
Location
at Oakland, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

β-thalassemia Ineffective Erythropoiesis Chronic anemia Thalassemia beta-Thalassemia PTG-300

Eligibility

You can join if…

Open to people ages 12-65

  • NTD and TD β-thalassemia subjects who completed Week 12 and Week 16 respectively in Study PTG-300-02.

You CAN'T join if...

  • Subjects who discontinued prematurely from study 300-02 (before Week 12 in NTD and Week 16 in TD).

Locations

  • UCSF Benioff Children's Hospital accepting new patients
    Oakland California 94609 United States
  • Boston Children's Hospital accepting new patients
    Boston Massachusetts 02215 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Protagonist Therapeutics, Inc.
ID
NCT04054921
Phase
Phase 2
Study Type
Interventional
Last Updated