Safety Study for Beta Thalassemia Subjects on PTG-300

Protagonist Therapeutics, Inc.34 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

β-thalassemia Ineffective Erythropoiesis

Interventions

PTG-300DRUG

PTG-300 is a hepcidin Mimetic

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * NTD and TD β-thalassemia subjects who completed Week 12 and Week 16 respectively in Study PTG-300-02. Exclusion Criteria: * Subjects who discontinued prematurely from study 300-02 (before Week 12 in NTD and Week 16 in TD).

Locations (16)

UCSF Benioff Children's Hospital

Oakland, California, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Laiko General Hospital of Athens

Outcomes

Primary Outcomes

Proportion of subjects with side effects and severity of side effects will be tabulated

the long-term safety and tolerability of PTG-300 in Beta Thalassemia.

Time frame: Over two year Period after receiving PTG-300

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.