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Completed

NCT Number: NCT04054921

Safety Study for Beta Thalassemia Subjects on PTG-300

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

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Key information

Conditions

β-thalassemia Ineffective Erythropoiesis

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Athens General Hospital 'G Gennimatas', Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PTG-300

Drug

PTG-300 is a hepcidin Mimetic

Primary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Protagonist Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: TRANSCEND

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2019
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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