Hemochromatosis Clinical Trials

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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 (96) 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 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).

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
RECRUITING
Indianapolis
Louisiana
Ochsner Medical Complex - High Grove
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
RECRUITING
Bethesda
James M. Stockman Cancer Institute
RECRUITING
Frederick
Michigan
University of Michigan Health System (UMHS)
NOT_YET_RECRUITING
Ann Arbor
Minnesota
Aspirus St. Luke's Clinic - Duluth - Oncology & Hematology
RECRUITING
Duluth
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Duke University Medical Center (Duke South Clinics) -40 Duke Medicine Cir
RECRUITING
Durham
New Jersey
Hunterdon Hematology Oncology, LLC
NOT_YET_RECRUITING
Flemington
Oklahoma
Hightower Clinical - Oklahoma Cancer Center
RECRUITING
Oklahoma City
Pennsylvania
Cancer Care Associates of York
NOT_YET_RECRUITING
York
Utah
Intermountain Medical Center
NOT_YET_RECRUITING
Murray
Washington
Velocity Clinical Research - Seattle
RECRUITING
Seattle
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
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
RECRUITING
Marseille
CHU de Montpellier- Hôpital Saint Eloi
RECRUITING
Montpellier
GHRMSA
NOT_YET_RECRUITING
Mulhouse
CHU de Bordeaux - Hôpital Haut Leveque
RECRUITING
Pessac
Centre Hospitalier Lyon Sud/Hospices Civils de Lyon
RECRUITING
Pierre-bénite
Chu Rennes
RECRUITING
Rennes
Centre Hospitalier de Saint Brieuc
RECRUITING
Saint-brieuc
CHU Toulouse
RECRUITING
Toulouse
Hôpital Paul Brousse
NOT_YET_RECRUITING
Villejuif
Germany
Universitätsklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
University Hospital Heidelberg
RECRUITING
Heidelberg
EUGASTRO GmbH
RECRUITING
Leipzig
MVZ für Innere Medizin Weinheim
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
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
RECRUITING
Verona
Netherlands
Maastricht UMC
NOT_YET_RECRUITING
Maastricht
Radboud UMC
RECRUITING
Nijmegen
New Zealand
Aotearoa Clinical Trials Trust- Middlemore Hospital
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
RECRUITING
Baloteşti
Bistrița County Emergency Clinical Hospital
RECRUITING
Bistriţa
Coltea Clinical Hospital
NOT_YET_RECRUITING
Bucharest
L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN)
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
RECRUITING
Barcelona
HUGC Doctor Negrin
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
RECRUITING
Manresa
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Switzerland
University Hospital Inselspital Bern
NOT_YET_RECRUITING
Bern
Centre Hospitalier Universitaire Vaudois
NOT_YET_RECRUITING
Lausanne
Epatocentro Ticino
RECRUITING
Lugano
United Kingdom
Royal Victoria Hospital
NOT_YET_RECRUITING
Belfast
University Hospitals Bristol and Weston NHS trust, Bristol Haematology and Oncology Centre
RECRUITING
Bristol
University Hospital Hairmyres-PPDS
NOT_YET_RECRUITING
Glasgow
Royal Liverpool University Hospital
RECRUITING
Liverpool
King's College Hospital
NOT_YET_RECRUITING
London
St Thomas Hospital
NOT_YET_RECRUITING
London
Norfolk and Norwich University Hospital
RECRUITING
Norwich
Nottingham University Hospitals City Campus
RECRUITING
Nottingham
John Radcliffe Hospital - Oxford University Hospitals NHS
NOT_YET_RECRUITING
Oxford
Derriford Hospital
RECRUITING
Plymouth
University Hospital Southampton NHS Foundation Trust
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

This content was sourced from clinicaltrials.gov