RECRUITING
Phase 2
ClinicalTrials.gov
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Sponsor: CSL Behring • ClinicalTrials.gov ID: NCT07332091
Registry updated: 2026-09-16
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Check Eligibility →Description
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.
Interventions
-
Vamifeport
(Drug)
Vamifeport capsule administered orally.
-
Placebo
(Drug)
Placebo capsule matching IP administered orally.
Eligibility criteria
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.
Conditions
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Locations
- Banner MD Anderson — Gilbert, Arizona, United States
- Infinity Clinical Trials — San Diego, California, United States
- Medical Oncology Associates of San Diego — San Diego, California, United States
- Green Leaf Clinical Trials — Jacksonville, Florida, United States
- Global Medical Research Management — Plantation, Florida, United States
- Indiana University Health University Hospital — Indianapolis, Indiana, United States
- Ochsner Medical Complex - High Grove — Baton Rouge, Louisiana, United States
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
- American Oncology Partners, PA dba The Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
- James M. Stockman Cancer Institute — Frederick, Maryland, United States
- University of Michigan Health System (UMHS) — Ann Arbor, Michigan, United States
- Aspirus St. Luke's Clinic - Duluth - Oncology & Hematology — Duluth, Minnesota, United States
- Hunterdon Hematology Oncology, LLC — Flemington, New Jersey, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Duke University Medical Center (Duke South Clinics) -40 Duke Medicine Cir — Durham, North Carolina, United States
- Hightower Clinical - Oklahoma Cancer Center — Oklahoma City, Oklahoma, United States
- Cancer Care Associates of York — York, Pennsylvania, United States
- Intermountain Medical Center — Murray, Utah, United States
- Velocity Clinical Research - Seattle — Seattle, Washington, United States
- Washington State Univ Elson S. Floyd College of Medicine — Spokane, Washington, United States
- Gallipoli Medical Research — Chandler, Queensland, Australia
- Royal Brisbane and Women's Hospital — Brisbane, Australia
- Monash Medical Centre — Clayton, Australia
- Trials West — Perth, Australia
- Westmead Hospital for Medical Research — Westmead, Australia
- Medical University of Innsbruck — Innsbruck, Austria
- Ordensklinikum Linz - Barmherzige Schwestern — Linz, Austria
- Medical University Vienna — Vienna, Austria
- Ghent University Hospital — Ghent, West Vlaanderen, Belgium
- Universitair Ziekenhuis Antwerpen (UZA) — Edegem, 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
- 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
- Aphp Avicenne — Bobigny, Île-de-France Region, 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, New Zealand
- Aotearoa Clinical Trials Trust- Middlemore Hospital — Auckland, 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
- Bistrița 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, 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
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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