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Trial · Interventional

CompletedPhase 2Registry data

Safety Study for Beta Thalassemia Subjects on PTG-300

Short name TRANSCEND

Overview

Status
Completed
Phase
Phase 2
Enrollment
34 participants (actual)
Sponsor
Protagonist Therapeutics, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
8 countries

United States, Greece, Lebanon, Malaysia, Thailand, Tunisia, Turkey (Türkiye), United Kingdom

Start
10 May 2019
Primary completion
31 Jul 2020
Completion
31 Jul 2020
First posted
13 Aug 2019
Last update posted
16 Jul 2021
Conditions
β-thalassemia · Ineffective Erythropoiesis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 2

    TRANSCEND

    NCT04054921

    10 May 2019 to 31 Jul 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • PTG-300Drug

Arms1

  • Experimental

    Interventions

    PTG-300

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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