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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04054921
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Protagonist Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
β-thalassemia Ineffective Erythropoiesis Drug: PTG-300 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Extension Study of PTG-300 In Non-Transfusion Depenent (NTD) and Trasfusion-Dependent (TD) B-Thalassemia Subjects
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : May 10, 2021
Estimated Study Completion Date : May 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventions
PTG-300
 Drug: PTG-300
PTG-300 is ahepcidin Mimetic
Other Name: Experimental Part 1


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054921


Contacts
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Contact: Nishit Modi, PhD 1-888-899-1543 ptgxclintrials@ptgx-inc.com

Locations
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United States, California
UCSF Benioff Children's Hospital Recruiting
Oakland, California, United States, 94609
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Greece
Laiko General Hospital of Athens Recruiting
Athens, Greece, 11526
Athens General Hospital 'G Gennimatas' Recruiting
Athens, Greece, 11527
University General Hospital of Patras Recruiting
Patras, Greece, 26500
Lebanon
Chronic Care Center Recruiting
Hazmiyeh, Lebanon
Malaysia
Hospital Ampang Recruiting
Ampang, Malaysia, 68000
Hospital Umum Sarawak Recruiting
Kuching, Malaysia, 93586
Thailand
Siriraj Hospital Mahidol University Recruiting
Bangkok, Thailand, 10700
Khon Kaen University Recruiting
Khon Kaen, Thailand, 40002
Chulalongkorn University Recruiting
Pathum Wan, Thailand, 10330
Naresuan University Recruiting
Phitsanulok, Thailand, 65000
Tunisia
University Hospital Farhat Hached Recruiting
Sousse, Tunisia, 4000
Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi Recruiting
Istanbul, Turkey, 34093
Ege Universitesi Tip Fakultesi Recruiting
Izmir, Turkey, 35100
United Kingdom
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Protagonist Therapeutics, Inc.
More Information
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Responsible Party: Protagonist Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04054921    
Other Study ID Numbers: PTG-300-03
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Protagonist Therapeutics, Inc.:
Chronic anemia
β-thalassemia
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn