Status:

COMPLETED

Safety Study for Beta Thalassemia Subjects on PTG-300

Lead Sponsor:

Protagonist Therapeutics, Inc.

Conditions:

β-thalassemia

Ineffective Erythropoiesis

Eligibility:

All Genders

12-65 years

Phase:

PHASE2

Brief 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 fr...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

May 10 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2020

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT04054921

Start Date

May 10 2019

End Date

July 31 2020

Last Update

July 16 2021

Active Locations (16)

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Page 1 of 4 (16 locations)

1

UCSF Benioff Children's Hospital

Oakland, California, United States, 94609

2

Boston Children's Hospital

Boston, Massachusetts, United States, 02215

3

Laiko General Hospital of Athens

Athens, Greece, 11526

4

Athens General Hospital 'G Gennimatas'

Athens, Greece, 11527