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Trial · Interventional

CompletedPhase 2Results postedRegistry data

PTG-300 in Subjects With Hereditary Hemochromatosis

NCTNCT04202965 (opens ClinicalTrials.gov in a new tab)Other idPTG-300-06
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Canada

Start
19 Mar 2020
Primary completion
6 Oct 2021
Completion
15 Feb 2022
First posted
18 Dec 2019
Last update posted
20 Aug 2025
Conditions
Hereditary Hemochromatosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. Ph 2

    PTG-300 in Subjects With Hereditary Hemochromatosis

    NCT04202965

    19 Mar 2020 to 15 Feb 2022

Registry summary

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

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.

Interventions

  • PTG-300Drug

Arms1

  • Experimental

    PTG-300

    PTG-300 Subcutaneous

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Effect of PTG-300 on Transferrin Saturation

    Time frame · Week 24 (or End of Treatment if treated for less than 24 weeks)

    Registry description

    Change from Baseline to Week 24 (or End of Treatment) in transferrin saturation (TSAT) as measured by blood laboratory tests.

  2. Effect of PTG-300 on Serum Iron

    Time frame · Week 24 (or End of Treatment if treated for less than 24 weeks)

    Registry description

    Change from Baseline to Week 24 (or End of Treatment) in serum iron as measured by blood laboratory tests.

Secondary outcomes(1)

  1. Effect of PTG-300 on Phlebotomy Frequency

    Time frame · Over 24 weeks

    Registry description

    Change in number of phlebotomies in 24-weeks before treatment compared with the number of phlebotomies during 24-weeks of treatment with PTG-300.

Posted results

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

Primary outcome results

Primary outcomeMean· Week 24 (or End of Treatment if treated for less than 24 weeks)

Effect of PTG-300 on Transferrin Saturation

GroupValue (percent saturation)Spread
PTG-300-6.0719.4
Primary outcomeMean· Week 24 (or End of Treatment if treated for less than 24 weeks)

Effect of PTG-300 on Serum Iron

GroupValue (micromol/L)Spread
PTG-300-2.349.76
Secondary and other outcome results(3)
Secondary outcomeMean· Over 24 weeks

Effect of PTG-300 on Phlebotomy Frequency

GroupValue (phlebotomies/week)Spread
PTG-3000.000.01
Other pre specified outcomeMean· Week 24 (or End of Treatment if treated for less than 24 weeks)

Mental Component Summary of SF-36

GroupValue (units on a scale)Spread
PTG-300-0.2519.379
Other pre specified outcomeMean· Week 24 (or End of Treatment if treated for less than 24 weeks)

Physical Component Summary of SF-36

GroupValue (units on a scake)Spread
PTG-3002.2636.528

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PTG-300PTG-300: Active treatment with PTG-300 subcutaneously0 / 161 / 1612 / 16

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2023

10 results

Rusfertide for the treatment of iron overload in HFE-related haemochromatosis: an open-label, multicentre, proof-of-concept phase 2 trial.

Kowdley et al. 2023The lancet. Gastroenterology & hepatologycited by 26

PMID 37863080DOI 10.1016/s2468-1253(23)00250-9PUB-37863080

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 * Any surgical procedures requiring general anesthesia within 1 month prior to screening or planned surgery during study * History of invasive malignancies within last 2 years, except non-malignant skin cancer and local cured prostate cancer, cervical cancer, or ductal carcinoma in situ * Receipt of an investigational agent within 30 days of screening

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