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New pill could ease iron overload for thousands with genetic disorder

NCT ID NCT07332091

Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 17, 2026 · Updated 11 times

Summary

This phase 2 trial tests an experimental drug called vamifeport in 84 adults with HFE-related hereditary hemochromatosis, a genetic condition causing iron buildup. The drug aims to reduce liver iron levels, potentially offering an alternative to regular blood removal. Participants take vamifeport or a placebo daily for several months, with MRI scans tracking changes in liver iron.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vamifeport
What this could lead to
If successful, vamifeport could offer a new oral treatment to control iron overload in hereditary hemochromatosis, potentially reducing the need for regular blood removal (phlebotomy).
What could go wrong
This is an early phase 2 proof-of-concept study with only 84 participants. It may fail to show significant reduction in liver iron, and long-term safety and efficacy are not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 2.4 and 16 mg/g (43.0 and 286.5 mmol/kg) dry weight (dw) at Screening. * Body mass index between 18.5 and 34.9 kilograms per meter squared (kg/m\^2). Exclusion Criteria: * Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.

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Conditions

The condition(s) this trial relates to.

hemochromatosis type 1 hereditary hemochromatosis Iron Overload

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Homeostatic iron regulator gene-related hereditary hemochromatosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    100 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AORN Cardarelli

    NOT_YET_RECRUITING

    Naples, Italy

  • ASL Brindisi - Presidio Ospedaliero Di Summa - Perrino

    NOT_YET_RECRUITING

    Brindisi, Italy

  • Aarhus University Hospital

    NOT_YET_RECRUITING

    Aarhus, Denmark

  • Althaia Foundation. Hospital Sant Joan de Deu de Manresa

    RECRUITING

    Manresa, Spain

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

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Aotearoa Clinical Trials Trust- Middlemore Hospital

    RECRUITING

    Auckland, 2025, New Zealand

  • Aphp Avicenne

    RECRUITING

    Bobigny, Île-de-France Region, 93000, France

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

    RECRUITING

    Duluth, Minnesota, 55805, United States

  • Auckland City Hospital

    NOT_YET_RECRUITING

    Auckland, 1023, New Zealand

  • Banner MD Anderson

    NOT_YET_RECRUITING

    Gilbert, Arizona, 85234-2165, United States

  • Beaumont Hospital

    NOT_YET_RECRUITING

    Dublin, Ireland

  • Bispebjerg Hospital

    NOT_YET_RECRUITING

    Copenhagen, Denmark

  • Bistrița County Emergency Clinical Hospital

    RECRUITING

    Bistriţa, Romania

  • CHU Toulouse

    RECRUITING

    Toulouse, France

  • CHU UCL Namur - Site Godinne

    NOT_YET_RECRUITING

    Yvoir, Belgium

  • CHU de Bordeaux - Hôpital Haut Leveque

    RECRUITING

    Pessac, France

  • CHU de Montpellier- Hôpital Saint Eloi

    RECRUITING

    Montpellier, France

  • CRMR Maladies du Globule Rouge, Hôpital de la Timone

    RECRUITING

    Marseille, France

  • Cancer Care Associates of York

    NOT_YET_RECRUITING

    York, Pennsylvania, 17403-5060, United States

  • Centre Hospitalier Lyon Sud/Hospices Civils de Lyon

    RECRUITING

    Pierre-Bénite, France

  • Centre Hospitalier Universitaire Vaudois

    NOT_YET_RECRUITING

    Lausanne, Switzerland

  • Centre Hospitalier Universitaire de Liège (CHU de Liège)

    NOT_YET_RECRUITING

    Liège, Belgium

  • Centre Hospitalier de Saint Brieuc

    RECRUITING

    Saint-Brieuc, France

  • Chu Dupuytren

    NOT_YET_RECRUITING

    Limoges, France

  • Chu Rennes

    RECRUITING

    Rennes, France

  • Coltea Clinical Hospital

    NOT_YET_RECRUITING

    Bucharest, Romania

  • Connolly Hospital Blanchardstown

    NOT_YET_RECRUITING

    Dublin, Ireland

  • Copenhagen University Hospital - Hvidovre

    NOT_YET_RECRUITING

    Hvidovre, Denmark

  • Cork University Hospital

    NOT_YET_RECRUITING

    Cork, Ireland

  • Derriford Hospital

    RECRUITING

    Plymouth, United Kingdom

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

    RECRUITING

    Durham, North Carolina, 27710-4000, United States

  • EUGASTRO GmbH

    RECRUITING

    Leipzig, Germany

  • Epatocentro Ticino

    RECRUITING

    Lugano, Switzerland

  • Fakultni nemocnice Ostrava

    NOT_YET_RECRUITING

    Ostrava, Czechia

  • Fakultní Nemocnice Brno

    NOT_YET_RECRUITING

    Brno, Czechia

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Italy

  • Fondazione IRCCS San Gerardo dei Tintori

    NOT_YET_RECRUITING

    Monza, Italy

  • GHRMSA

    NOT_YET_RECRUITING

    Mulhouse, France

  • Gallipoli Medical Research

    RECRUITING

    Chandler, Queensland, 4120, Australia

  • Ghent University Hospital

    RECRUITING

    Ghent, West Vlaanderen, 9000, Belgium

  • Global Medical Research Management

    RECRUITING

    Plantation, Florida, 33324, United States

  • Green Leaf Clinical Trials

    RECRUITING

    Jacksonville, Florida, 32258, United States

  • HUGC Doctor Negrin

    RECRUITING

    LAS Palmas de GC, Spain

  • Hightower Clinical - Oklahoma Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73174, United States

  • Hospital Clinic Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Universitari Germans Trias i Pujol

    NOT_YET_RECRUITING

    Badalona, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    NOT_YET_RECRUITING

    Majadahonda, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Spain

  • Hunterdon Hematology Oncology, LLC

    NOT_YET_RECRUITING

    Flemington, New Jersey, 08822, United States

  • Hôpital Paul Brousse

    NOT_YET_RECRUITING

    Villejuif, France

  • Indiana University Health University Hospital

    RECRUITING

    Indianapolis, Indiana, 46202-5149, United States

  • Infinity Clinical Trials

    NOT_YET_RECRUITING

    San Diego, California, 92108, United States

  • Institut Klinicke a Experimentalni Mediciny

    NOT_YET_RECRUITING

    Prague, Czechia

  • Instytut Hematologii i Transfuzjologii

    NOT_YET_RECRUITING

    Warsaw, Poland

  • Intermountain Medical Center

    NOT_YET_RECRUITING

    Murray, Utah, 84107, United States

  • James M. Stockman Cancer Institute

    RECRUITING

    Frederick, Maryland, 21702-4337, United States

  • John Radcliffe Hospital - Oxford University Hospitals NHS

    NOT_YET_RECRUITING

    Oxford, United Kingdom

  • Johns Hopkins University School of Medicine

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21205, United States

  • King's College Hospital

    NOT_YET_RECRUITING

    London, United Kingdom

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

    RECRUITING

    Cluj-Napoca, Romania

  • Libin Cardiovascular Institute University of Calgary

    NOT_YET_RECRUITING

    Calgary, Canada

  • MVZ für Innere Medizin Weinheim

    RECRUITING

    Weinheim, Germany

  • Maastricht UMC

    NOT_YET_RECRUITING

    Maastricht, Netherlands

  • McMaster University-St. Josephs Healthcare Hamilton

    NOT_YET_RECRUITING

    Hamilton, Canada

  • Medical Oncology Associates of San Diego

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Medical University Vienna

    NOT_YET_RECRUITING

    Vienna, Austria

  • Medical University of Innsbruck

    NOT_YET_RECRUITING

    Innsbruck, Austria

  • Monash Medical Centre

    NOT_YET_RECRUITING

    Clayton, Australia

  • Norfolk and Norwich University Hospital

    RECRUITING

    Norwich, United Kingdom

  • Nottingham University Hospitals City Campus

    RECRUITING

    Nottingham, United Kingdom

  • Ochsner Medical Complex - High Grove

    RECRUITING

    Baton Rouge, Louisiana, 70836, United States

  • Ordensklinikum Linz - Barmherzige Schwestern

    NOT_YET_RECRUITING

    Linz, Austria

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

    NOT_YET_RECRUITING

    Cluj-Napoca, Romania

  • Radboud UMC

    RECRUITING

    Nijmegen, Netherlands

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Brisbane, 4006, Australia

  • Royal Liverpool University Hospital

    RECRUITING

    Liverpool, United Kingdom

  • Royal Victoria Hospital

    NOT_YET_RECRUITING

    Belfast, United Kingdom

  • South Warwickshire University Foundation Trust

    NOT_YET_RECRUITING

    Warwick, United Kingdom

  • Specjalistyczny Szpital im. Alfreda Sokolowskiego

    NOT_YET_RECRUITING

    Wałbrzych, Poland

  • Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu-Balotesti

    RECRUITING

    Baloteşti, Romania

  • St Thomas Hospital

    NOT_YET_RECRUITING

    London, United Kingdom

  • Trials West

    RECRUITING

    Perth, Australia

  • UZ Brussel

    NOT_YET_RECRUITING

    Jette, Belgium

  • Universitair Ziekenhuis Antwerpen (UZA)

    NOT_YET_RECRUITING

    Edegem, Belgium

  • University Hospital Hairmyres-PPDS

    RECRUITING

    Glasgow, Glasgow City Region, SE5 9RS, United Kingdom

  • University Hospital Heidelberg

    RECRUITING

    Heidelberg, Germany

  • University Hospital Inselspital Bern

    NOT_YET_RECRUITING

    Bern, Switzerland

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, United Kingdom

  • University Hospital of Modena

    NOT_YET_RECRUITING

    Modena, Italy

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

    RECRUITING

    Bristol, United Kingdom

  • University of Manitoba

    NOT_YET_RECRUITING

    Winnipeg, Canada

  • University of Michigan Health System (UMHS)

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27517-7518, United States

  • University of Verona - Azienda Ospedaliera Universitaria Integrata Verona

    RECRUITING

    Verona, Italy

  • Universitätsklinikum Freiburg

    NOT_YET_RECRUITING

    Freiburg im Breisgau, Germany

  • Velocity Clinical Research - Seattle

    RECRUITING

    Seattle, Washington, 98105, United States

  • Washington State Univ Elson S. Floyd College of Medicine

    RECRUITING

    Spokane, Washington, 99202-2131, United States

  • Westmead Hospital for Medical Research

    RECRUITING

    Westmead, 2145, Australia

  • Wojewodzki Szpital im. J Gromkowskiego we Wroclawiu

    NOT_YET_RECRUITING

    Wroclaw, Poland