Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
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)
2 other identifiers
interventional
84
17 countries
93
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2026
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2026
CompletedFirst Posted
Study publicly available on registry
January 12, 2026
CompletedStudy Start
First participant enrolled
January 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 6, 2028
March 27, 2026
March 1, 2026
2.1 years
January 8, 2026
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC)
At Baseline and Day 360
Secondary Outcomes (27)
Number of participants with treatment-emergent adverse events (TEAEs)
Up to Day 390
Percentage of participants with TEAEs
Up to Day 390
Number of participants with treatment-emergent serious adverse events (SAEs)
Up to Day 390
Percentage of participants with treatment-emergent SAEs
Up to Day 390
Number of participants with clinically significant change from baseline in clinical safety laboratory tests and 12-lead electrocardiogram (ECG)
From Baseline to Day 390
- +22 more secondary outcomes
Study Arms (3)
Vamifeport Low Dose
EXPERIMENTALParticipants will receive a low dose of vamifeport orally, twice daily (BID) up to Day 360.
Vamifeport High Dose
EXPERIMENTALParticipants will receive a high dose of vamifeport orally, BID up to Day 360.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matching vamifeport low and high doses orally, BID up to Day 360.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (96)
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
Intermountain Medical Center
Murray, Utah, 84107, 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
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2026
First Posted
January 12, 2026
Study Start
January 22, 2026
Primary Completion (Estimated)
March 6, 2028
Study Completion (Estimated)
April 6, 2028
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
- Access Criteria
- Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.