Safety Study for Beta Thalassemia Subjects on PTG-300 (TRANSCEND)

July 12, 2021 updated by: Protagonist Therapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11526
        • Laiko General Hospital of Athens
      • Athens, Greece, 11527
        • Athens General Hospital 'G Gennimatas'
      • Patras, Greece, 26500
        • University General Hospital of Patras
  • Lebanon
      • Hazmiyeh, Lebanon
        • Chronic Care Center
  • Malaysia
      • Ampang, Malaysia, 68000
        • Hospital Ampang
      • Kuching, Malaysia, 93586
        • Hospital Umum Sarawak
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital Mahidol University
      • Khon Kaen, Thailand, 40002
        • Khon Kaen University
      • Pathum Wan, Thailand, 10330
        • Chulalongkorn University
      • Phitsanulok, Thailand, 65000
        • Naresuan University
  • Tunisia
      • Sousse, Tunisia, 4000
        • University Hospital Farhat Hached
  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
      • Izmir, Turkey, 35100
        • Ege Universitesi Tip Fakultesi
  • United Kingdom
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust
  • United States
    • California
      • Oakland, California, United States, 94609
        • UCSF Benioff Children's Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventions
PTG-300
Drug: PTG-300
PTG-300 is a hepcidin Mimetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Over two year Period after receiving PTG-300

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protagonist Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2019

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTG-300-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on β-thalassemia

Clinical Trials on PTG-300

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe