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NCT07332091PHASE2Recruiting

Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis

CSL Behring

Start Date

1/22/2026

Completion Date

4/6/2028

Summary

This is a phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study to assess vamifeport in adult participants with homeostatic iron regulator gene-related hereditary hemochromatosis (HFE-HH). The primary objective of the study is to assess the effect of vamifeport treatment on magnetic resonance imaging (MRI)-based liver iron concentration (LIC) in adult participants with HFE-HH.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adult (≥ 18 years) and has provided written informed consent. * Confirmed diagnosis of HFE-HH in medical history. * Evidence of iron overload as shown by: * TSAT \> 45% (confirmed at 2 visits, at least 14 days apart) at Screening; and * Serum ferritin ≥ 200 nanogram per milliliter (ng/mL) and \< 5000 ng/mL (confirmed at 2 visits, at least 14 days apart) at Screening; and * MRI-based LIC between 3 and 16 mg/g (53.7 and 286.5 millimol per kilogram \[mmol/kg\]) dry weight (dw) at Screening. * Body mass index between 18.5 and 32 kilograms per meter squared (kg/m\^2). Exclusion Criteria: * Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.

Interventions

DRUG

Vamifeport

DRUG

Placebo

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Conditions

Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis

Locations

Banner MD Anderson

Gilbert, Arizona 85234-2165

United States

Infinity Clinical Trials

San Diego, California 92108

United States

Medical Oncology Associates of San Diego

San Diego, California 92123

United States

Green Leaf Clinical Trials

Jacksonville, Florida 32258

United States

Indiana University Health University Hospital

Indianapolis, Indiana 46202-5149

United States

Ochsner Medical Complex - High Grove

Baton Rouge, Louisiana 70836

United States

Johns Hopkins University School of Medicine

Baltimore, Maryland 21205

United States

American Oncology Partners, PA dba The Center for Cancer and Blood Disorders

Bethesda, Maryland 20817

United States

James M. Stockman Cancer Institute

Frederick, Maryland 21702-4337

United States

University of Michigan Health System (UMHS)

Ann Arbor, Michigan 48109

United States

Aspirus St. Luke's Clinic - Duluth - Oncology & Hematology

Duluth, Minnesota 55805

United States

Hunterdon Hematology Oncology, LLC

Flemington, New Jersey 08822

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27517-7518

United States

Duke University Medical Center (Duke South Clinics) -40 Duke Medicine Cir

Durham, North Carolina 27710-4000

United States

Hightower Clinical - Oklahoma Cancer Center

Oklahoma City, Oklahoma 73174

United States

Cancer Care Associates of York

York, Pennsylvania 17403-5060

United States

Intermountain Medical Center

Murray, Utah 84107

United States

Velocity Clinical Research-Seattle

Seattle, Washington 98105

United States

Washington State Univ Elson S. Floyd College of Medicine

Spokane, Washington 99202-2131

United States

Royal Brisbane and Women's Hospital

Brisbane,

Australia

Gallipoli Medical Research

Chandler,

Australia

Monash Medical Centre

Clayton,

Australia

Trials West

Perth,

Australia

Westmead Hospital for Medical Research

Westmead, 2145

Australia

Medical University of Innsbruck

Innsbruck,

Austria

Ordensklinikum Linz - Barmherzige Schwestern

Linz,

Austria

Medical University Vienna

Vienna,

Austria

Universitair Ziekenhuis Antwerpen (UZA)

Edegem,

Belgium

Ghent University Hospital

Ghent,

Belgium

UZ Brussel

Jette,

Belgium

Centre Hospitalier Universitaire de Liège (CHU de Liège)

Liège,

Belgium

CHU UCL Namur - Site Godinne

Yvoir,

Belgium

Libin Cardiovascular Institute University of Calgary

Calgary,

Canada

McMaster University-St. Josephs Healthcare Hamilton

Hamilton,

Canada

University of Manitoba

Winnipeg,

Canada

Fakultní Nemocnice Brno

Brno,

Czechia

Fakultni nemocnice Ostrava

Ostrava,

Czechia

Institut Klinicke a Experimentalni Mediciny

Prague,

Czechia

Aarhus University Hospital

Aarhus,

Denmark

Bispebjerg Hospital

Copenhagen,

Denmark

Copenhagen University Hospital - Hvidovre

Hvidovre,

Denmark

Aphp Avicenne

Bobigny,

France

Chu Dupuytren

Limoges,

France

CRMR Maladies du Globule Rouge, Hôpital de la Timone

Marseille,

France

CHU de Montpellier- Hôpital Saint Eloi

Montpellier,

France

GHRMSA

Mulhouse,

France

CHU de Bordeaux - Hôpital Haut Leveque

Pessac,

France

Centre Hospitalier Lyon Sud/Hospices Civils de Lyon

Pierre-Bénite,

France

Chu Rennes

Rennes,

France

Centre Hospitalier de Saint Brieuc

Saint-Brieuc,

France

CHU Toulouse

Toulouse,

France

Hôpital Paul Brousse

Villejuif,

France

Universitätsklinikum Freiburg

Freiburg im Breisgau,

Germany

University Hospital Heidelberg

Heidelberg,

Germany

EUGASTRO GmbH

Leipzig,

Germany

MVZ für Innere Medizin Weinheim

Weinheim,

Germany

Cork University Hospital

Cork,

Ireland

Beaumont Hospital

Dublin,

Ireland

Connolly Hospital Blanchardstown

Dublin,

Ireland

ASL Brindisi - Presidio Ospedaliero Di Summa - Perrino

Brindisi,

Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan,

Italy

University Hospital of Modena

Modena,

Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza,

Italy

AORN Cardarelli

Naples,

Italy

University of Verona - Azienda Ospedaliera Universitaria Integrata Verona

Verona,

Italy

Maastricht UMC

Maastricht,

Netherlands

Radboud UMC

Nijmegen,

Netherlands

Auckland City Hospital

Auckland, 1023

New Zealand

Aotearoa Clinical Trials Trust- Middlemore Hospital

Auckland, 2025

New Zealand

Instytut Hematologii i Transfuzjologii

Warsaw,

Poland

Specjalistyczny Szpital im. Alfreda Sokolowskiego

Wałbrzych,

Poland

Wojewodzki Szpital im. J Gromkowskiego we Wroclawiu

Wroclaw,

Poland

Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu-Balotesti

Baloteşti,

Romania

Bistrita County Emergency Clinical Hospital

Bistriţa,

Romania

Coltea Clinical Hospital

Bucharest,

Romania

L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN)

Cluj-Napoca,

Romania

Prof. Dr.Octavian Fodor Regional Institute of Gastroenterology-Hepatology

Cluj-Napoca,

Romania

Hospital Universitari Germans Trias i Pujol

Badalona,

Spain

Hospital Clinic Barcelona

Barcelona,

Spain

HUGC Doctor Negrin

LAS Palmas de GC,

Spain

Hospital Universitario La Paz

Madrid,

Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda,

Spain

Althaia Foundation. Hospital Sant Joan de Deu de Manresa

Manresa,

Spain

Hospital Universitario Virgen del Rocío

Seville,

Spain

University Hospital Inselspital Bern

Bern,

Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne,

Switzerland

Epatocentro Ticino

Lugano,

Switzerland

University Hospital Hairmyres-PPDS

Glasgow, Glasgow City Region SE5 9RS

United Kingdom

Royal Victoria Hospital

Belfast,

United Kingdom

University Hospitals Bristol and Weston NHS trust, Bristol Haematology and Oncology Centre

Bristol,

United Kingdom

Royal Liverpool University Hospital

Liverpool,

United Kingdom

King's College Hospital

London,

United Kingdom

St Thomas Hospital

London,

United Kingdom

Norfolk and Norwich University Hospital

Norwich,

United Kingdom

Nottingham University Hospitals City Campus

Nottingham,

United Kingdom

John Radcliffe Hospital - Oxford University Hospitals NHS

Oxford,

United Kingdom

Derriford Hospital

Plymouth,

United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton,

United Kingdom

South Warwickshire University Foundation Trust

Warwick,

United Kingdom