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COMPLETEDPHASE2

PTG-300 in Subjects With Hereditary Hemochromatosis

Open-label Study of PTG-300 in Subjects With Hereditary Hemochromatosis

NCT04202965•Protagonist Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This study will be conducted at multiple sites and every patient will get treated with PTG-300. The objective of the study is to assess the effect of PTG-300 in treating adult hereditary hemochromatosis patients.

Detailed Description

This study is a multicenter, open-label study. The objective of the study is to assess the effect of PTG-300 on transferrin saturation (TSAT) and serum iron in adult hereditary hemochromatosis patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Men and women aged 18 and older
•Confirmed diagnosis of HFE-related hereditary hemochromatosis with prior genotype testing
•Documented stable phlebotomy for ≥ 6 months
•Screening hemoglobin \>11.5 g/dL
•Documented evidence of prior serum ferritin ≥500 ng/mL
•Serum ferritin \>50 ng/mL and \<300 ng/mL at screening

Exclusion Criteria

•Clinically meaningful laboratory abnormality
•Receiving iron chelation therapy
•Receiving erythrocytapheresis
•Pregnant or lactating females
•Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infections requiring antimicrobial therapy within 4 weeks of dosing.
•Serious or unstable medical or psychiatric condition that would prevent subject providing informed consent
•Organ damage from iron overload
•Primary or secondary immunodeficiency
•Positive hepatitis B or hepatitis C or known human immunodeficiency virus infection
•Known history of autoimmune/inflammatory diseases
+3 more criteria

Locations (11)

Protagonist Investigational Site

Fayetteville, Georgia, United States

Protagonist Investigational Site

Bethesda, Maryland, United States

Protagonist Investigational Site

Charlotte, North Carolina, United States

Protagonist Investigational Site

Conroe, Texas, United States

Protagonist Investigational Site

Dallas, Texas, United States

Protagonist Investigational Site

Houston, Texas, United States

Protagonist Investigational Site

Houston, Texas, United States

Protagonist Investigational Site

Richmond, Virginia, United States

Protagonist Investigational Site

Seattle, Washington, United States

Protagonist Investigational Site

Halifax, Nova Scotia, Canada

Key Dates

Start Date

March 19, 2020

Primary Completion Date

October 6, 2021

Completion Date

February 15, 2022

Last Updated

August 20, 2025

Enrollment

16

ACTUAL participants

Conditions

Hereditary Hemochromatosis

Interventions

PTG-300

DRUG

Sponsors

Lead Sponsor

Protagonist Therapeutics, Inc.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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