A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects With HFE-related Hereditary Hemochromatosis (FERROCLEAR Study)
Status: Recruiting
Location: See all (93) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
United States
Arizona
Banner MD Anderson
NOT_YET_RECRUITING
Gilbert
California
Infinity Clinical Trials
NOT_YET_RECRUITING
San Diego
Medical Oncology Associates of San Diego
NOT_YET_RECRUITING
San Diego
Florida
Green Leaf Clinical Trials
RECRUITING
Jacksonville
Indiana
Indiana University Health University Hospital
NOT_YET_RECRUITING
Indianapolis
Louisiana
Ochsner Medical Complex - High Grove
NOT_YET_RECRUITING
Baton Rouge
Maryland
Johns Hopkins University School of Medicine
NOT_YET_RECRUITING
Baltimore
American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
NOT_YET_RECRUITING
Bethesda
James M. Stockman Cancer Institute
NOT_YET_RECRUITING
Frederick
Michigan
University of Michigan Health System (UMHS)
NOT_YET_RECRUITING
Ann Arbor
Minnesota
Aspirus St. Luke's Clinic - Duluth - Oncology & Hematology
NOT_YET_RECRUITING
Duluth
North Carolina
University of North Carolina at Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
Duke University Medical Center (Duke South Clinics) -40 Duke Medicine Cir
NOT_YET_RECRUITING
Durham
New Jersey
Hunterdon Hematology Oncology, LLC
NOT_YET_RECRUITING
Flemington
Oklahoma
Hightower Clinical - Oklahoma Cancer Center
NOT_YET_RECRUITING
Oklahoma City
Utah
Intermountain Medical Center
NOT_YET_RECRUITING
Murray
Washington
Washington State Univ Elson S. Floyd College of Medicine
RECRUITING
Spokane
Other Locations
Australia
Royal Brisbane and Women's Hospital
NOT_YET_RECRUITING
Brisbane
Gallipoli Medical Research
NOT_YET_RECRUITING
Chandler
Monash Medical Centre
NOT_YET_RECRUITING
Clayton
Trials West
NOT_YET_RECRUITING
Perth
Westmead Hospital for Medical Research
NOT_YET_RECRUITING
Westmead
Austria
Medical University of Innsbruck
NOT_YET_RECRUITING
Innsbruck
Ordensklinikum Linz - Barmherzige Schwestern
NOT_YET_RECRUITING
Linz
Medical University Vienna
NOT_YET_RECRUITING
Vienna
Belgium
Universitair Ziekenhuis Antwerpen (UZA)
NOT_YET_RECRUITING
Edegem
Ghent University Hospital
NOT_YET_RECRUITING
Ghent
UZ Brussel
NOT_YET_RECRUITING
Jette
Centre Hospitalier Universitaire de Liège (CHU de Liège)
NOT_YET_RECRUITING
Liège
CHU UCL Namur - Site Godinne
NOT_YET_RECRUITING
Yvoir
Canada
Libin Cardiovascular Institute University of Calgary
NOT_YET_RECRUITING
Calgary
McMaster University-St. Josephs Healthcare Hamilton
NOT_YET_RECRUITING
Hamilton
University of Manitoba
NOT_YET_RECRUITING
Winnipeg
Denmark
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Bispebjerg Hospital
NOT_YET_RECRUITING
Copenhagen
Copenhagen University Hospital - Hvidovre
NOT_YET_RECRUITING
Hvidovre
France
Aphp Avicenne
NOT_YET_RECRUITING
Bobigny
Chu Dupuytren
NOT_YET_RECRUITING
Limoges
CRMR Maladies du Globule Rouge, Hôpital de la Timone
NOT_YET_RECRUITING
Marseille
CHU de Montpellier- Hôpital Saint Eloi
NOT_YET_RECRUITING
Montpellier
GHRMSA
NOT_YET_RECRUITING
Mulhouse
CHU de Bordeaux - Hôpital Haut Leveque
NOT_YET_RECRUITING
Pessac
Centre Hospitalier Lyon Sud/Hospices Civils de Lyon
NOT_YET_RECRUITING
Pierre-bénite
Chu Rennes
NOT_YET_RECRUITING
Rennes
Centre Hospitalier de Saint Brieuc
NOT_YET_RECRUITING
Saint-brieuc
CHU Toulouse
NOT_YET_RECRUITING
Toulouse
Hôpital Paul Brousse
NOT_YET_RECRUITING
Villejuif
Germany
Universitätsklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
University Hospital Heidelberg
NOT_YET_RECRUITING
Heidelberg
EUGASTRO GmbH
NOT_YET_RECRUITING
Leipzig
MVZ für Innere Medizin Weinheim
NOT_YET_RECRUITING
Weinheim
Ireland
Cork University Hospital
NOT_YET_RECRUITING
Cork
Beaumont Hospital
NOT_YET_RECRUITING
Dublin
Connolly Hospital Blanchardstown
NOT_YET_RECRUITING
Dublin
Italy
ASL Brindisi - Presidio Ospedaliero Di Summa - Perrino
NOT_YET_RECRUITING
Brindisi
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
University Hospital of Modena
NOT_YET_RECRUITING
Modena
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
AORN Cardarelli
NOT_YET_RECRUITING
Naples
University of Verona - Azienda Ospedaliera Universitaria Integrata Verona
NOT_YET_RECRUITING
Verona
Netherlands
Maastricht UMC
NOT_YET_RECRUITING
Maastricht
Radboud UMC
NOT_YET_RECRUITING
Nijmegen
New Zealand
Aotearoa Clinical Trials Trust- Middlemore Hospital
NOT_YET_RECRUITING
Auckland
Auckland City Hospital
NOT_YET_RECRUITING
Auckland
Poland
Specjalistyczny Szpital im. Alfreda Sokolowskiego
NOT_YET_RECRUITING
Wałbrzych
Instytut Hematologii i Transfuzjologii
NOT_YET_RECRUITING
Warsaw
Wojewodzki Szpital im. J Gromkowskiego we Wroclawiu
NOT_YET_RECRUITING
Wroclaw
Romania
Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu-Balotesti
NOT_YET_RECRUITING
Baloteşti
Bistrița County Emergency Clinical Hospital
NOT_YET_RECRUITING
Bistriţa
Coltea Clinical Hospital
NOT_YET_RECRUITING
Bucharest
L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN)
NOT_YET_RECRUITING
Cluj-napoca
Prof. Dr.Octavian Fodor Regional Institute of Gastroenterology-Hepatology
NOT_YET_RECRUITING
Cluj-napoca
Spain
Hospital Universitari Germans Trias i Pujol
NOT_YET_RECRUITING
Badalona
Hospital Clinic Barcelona
NOT_YET_RECRUITING
Barcelona
HUGC Doctor Negrin
NOT_YET_RECRUITING
Las Palmas De Gc
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
NOT_YET_RECRUITING
Majadahonda
Althaia Foundation. Hospital Sant Joan de Deu de Manresa
NOT_YET_RECRUITING
Manresa
Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITING
Seville
Switzerland
University Hospital Inselspital Bern
NOT_YET_RECRUITING
Bern
Centre Hospitalier Universitaire Vaudois
NOT_YET_RECRUITING
Lausanne
Epatocentro Ticino
NOT_YET_RECRUITING
Lugano
United Kingdom
Royal Victoria Hospital
NOT_YET_RECRUITING
Belfast
University Hospitals Bristol and Weston NHS trust, Bristol Haematology and Oncology Centre
NOT_YET_RECRUITING
Bristol
Royal Liverpool University Hospital
NOT_YET_RECRUITING
Liverpool
King's College Hospital
NOT_YET_RECRUITING
London
St Thomas Hospital
NOT_YET_RECRUITING
London
Norfolk and Norwich University Hospital
NOT_YET_RECRUITING
Norwich
Nottingham University Hospitals City Campus
NOT_YET_RECRUITING
Nottingham
John Radcliffe Hospital - Oxford University Hospitals NHS
NOT_YET_RECRUITING
Oxford
Derriford Hospital
NOT_YET_RECRUITING
Plymouth
University Hospital Southampton NHS Foundation Trust
NOT_YET_RECRUITING
Southampton
South Warwickshire University Foundation Trust
NOT_YET_RECRUITING
Warwick
Contact Information
Primary
Trial Registration Coordinator
clinicaltrials@cslbehring.com
+16108784697
Time Frame
Start Date: 2026-01-22
Estimated Completion Date: 2028-04-06
Participants
Target number of participants: 84
Treatments
Experimental: Vamifeport Low Dose
Participants will receive a low dose of vamifeport orally, twice daily (BID) up to Day 360.
Experimental: Vamifeport High Dose
Participants will receive a high dose of vamifeport orally, BID up to Day 360.
Placebo_comparator: Placebo
Participants will receive placebo matching vamifeport low and high doses orally, BID up to Day 360.
Related Therapeutic Areas
Sponsors
Leads: CSL Behring