Actively Recruiting
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Led by CSL Behring · Updated on 2026-03-27
84
Participants Needed
96
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (≥ 18 years) and has provided written informed consent.
- Confirmed diagnosis of HFE-HH in medical history.
- Transferrin saturation (TSAT) > 45% confirmed at 2 visits at least 14 days apart at Screening.
- Serum ferritin ≥ 200 ng/mL and < 5000 ng/mL confirmed at 2 visits at least 14 days apart at Screening.
- MRI-based liver iron concentration (LIC) between 3 and 16 mg/g dry weight at Screening.
- Body mass index between 18.5 and 32 kg/m².
You will not qualify if you...
- Clinically relevant laboratory abnormalities.
- Abnormal 12-lead electrocardiogram (ECG) findings.
- Relevant medical history that may interfere with study participation or safety.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 96 locations
1
Banner MD Anderson
Gilbert, Arizona, United States, 85234-2165
Not Yet Recruiting
2
Infinity Clinical Trials
San Diego, California, United States, 92108
Not Yet Recruiting
3
Medical Oncology Associates of San Diego
San Diego, California, United States, 92123
Not Yet Recruiting
4
Green Leaf Clinical Trials
Jacksonville, Florida, United States, 32258
Actively Recruiting
5
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202-5149
Not Yet Recruiting
6
Ochsner Medical Complex - High Grove
Baton Rouge, Louisiana, United States, 70836
Not Yet Recruiting
7
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Not Yet Recruiting
8
American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Not Yet Recruiting
9
James M. Stockman Cancer Institute
Frederick, Maryland, United States, 21702-4337
Not Yet Recruiting
10
University of Michigan Health System (UMHS)
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
11
Aspirus St. Luke's Clinic - Duluth - Oncology & Hematology
Duluth, Minnesota, United States, 55805
Not Yet Recruiting
12
Hunterdon Hematology Oncology, LLC
Flemington, New Jersey, United States, 08822
Not Yet Recruiting
13
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27517-7518
Not Yet Recruiting
14
Duke University Medical Center (Duke South Clinics) -40 Duke Medicine Cir
Durham, North Carolina, United States, 27710-4000
Not Yet Recruiting
15
Hightower Clinical - Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States, 73174
Not Yet Recruiting
16
Intermountain Medical Center
Murray, Utah, United States, 84107
Not Yet Recruiting
17
Washington State Univ Elson S. Floyd College of Medicine
Spokane, Washington, United States, 99202-2131
Actively Recruiting
18
Royal Brisbane and Women's Hospital
Brisbane, Australia
Not Yet Recruiting
19
Gallipoli Medical Research
Chandler, Australia
Not Yet Recruiting
20
Monash Medical Centre
Clayton, Australia
Not Yet Recruiting
21
Trials West
Perth, Australia
Not Yet Recruiting
22
Westmead Hospital for Medical Research
Westmead, Australia, 2145
Not Yet Recruiting
23
Medical University of Innsbruck
Innsbruck, Austria
Not Yet Recruiting
24
Ordensklinikum Linz - Barmherzige Schwestern
Linz, Austria
Not Yet Recruiting
25
Medical University Vienna
Vienna, Austria
Not Yet Recruiting
26
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium
Not Yet Recruiting
27
Ghent University Hospital
Ghent, Belgium
Not Yet Recruiting
28
UZ Brussel
Jette, Belgium
Not Yet Recruiting
29
Centre Hospitalier Universitaire de Liège (CHU de Liège)
Liège, Belgium
Not Yet Recruiting
30
CHU UCL Namur - Site Godinne
Yvoir, Belgium
Not Yet Recruiting
31
Libin Cardiovascular Institute University of Calgary
Calgary, Canada
Not Yet Recruiting
32
McMaster University-St. Josephs Healthcare Hamilton
Hamilton, Canada
Not Yet Recruiting
33
University of Manitoba
Winnipeg, Canada
Not Yet Recruiting
34
Fakultní Nemocnice Brno
Brno, Czechia
Not Yet Recruiting
35
Fakultni nemocnice Ostrava
Ostrava, Czechia
Not Yet Recruiting
36
Institut Klinicke a Experimentalni Mediciny
Prague, Czechia
Not Yet Recruiting
37
Aarhus University Hospital
Aarhus, Denmark
Not Yet Recruiting
38
Bispebjerg Hospital
Copenhagen, Denmark
Not Yet Recruiting
39
Copenhagen University Hospital - Hvidovre
Hvidovre, Denmark
Not Yet Recruiting
40
Aphp Avicenne
Bobigny, France
Not Yet Recruiting
41
Chu Dupuytren
Limoges, France
Not Yet Recruiting
42
CRMR Maladies du Globule Rouge, Hôpital de la Timone
Marseille, France
Not Yet Recruiting
43
CHU de Montpellier- Hôpital Saint Eloi
Montpellier, France
Not Yet Recruiting
44
GHRMSA
Mulhouse, France
Not Yet Recruiting
45
CHU de Bordeaux - Hôpital Haut Leveque
Pessac, France
Not Yet Recruiting
46
Centre Hospitalier Lyon Sud/Hospices Civils de Lyon
Pierre-Bénite, France
Not Yet Recruiting
47
Chu Rennes
Rennes, France
Not Yet Recruiting
48
Centre Hospitalier de Saint Brieuc
Saint-Brieuc, France
Not Yet Recruiting
49
CHU Toulouse
Toulouse, France
Not Yet Recruiting
50
Hôpital Paul Brousse
Villejuif, France
Not Yet Recruiting
51
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Not Yet Recruiting
52
University Hospital Heidelberg
Heidelberg, Germany
Not Yet Recruiting
53
EUGASTRO GmbH
Leipzig, Germany
Not Yet Recruiting
54
MVZ für Innere Medizin Weinheim
Weinheim, Germany
Not Yet Recruiting
55
Cork University Hospital
Cork, Ireland
Not Yet Recruiting
56
Beaumont Hospital
Dublin, Ireland
Not Yet Recruiting
57
Connolly Hospital Blanchardstown
Dublin, Ireland
Not Yet Recruiting
58
ASL Brindisi - Presidio Ospedaliero Di Summa - Perrino
Brindisi, Italy
Not Yet Recruiting
59
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Not Yet Recruiting
60
University Hospital of Modena
Modena, Italy
Not Yet Recruiting
61
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Not Yet Recruiting
62
AORN Cardarelli
Naples, Italy
Not Yet Recruiting
63
University of Verona - Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Not Yet Recruiting
64
Maastricht UMC
Maastricht, Netherlands
Not Yet Recruiting
65
Radboud UMC
Nijmegen, Netherlands
Not Yet Recruiting
66
Auckland City Hospital
Auckland, New Zealand, 1023
Not Yet Recruiting
67
Aotearoa Clinical Trials Trust- Middlemore Hospital
Auckland, New Zealand, 2025
Not Yet Recruiting
68
Instytut Hematologii i Transfuzjologii
Warsaw, Poland
Not Yet Recruiting
69
Specjalistyczny Szpital im. Alfreda Sokolowskiego
Wałbrzych, Poland
Not Yet Recruiting
70
Wojewodzki Szpital im. J Gromkowskiego we Wroclawiu
Wroclaw, Poland
Not Yet Recruiting
71
Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu-Balotesti
Baloteşti, Romania
Not Yet Recruiting
72
Bistrița County Emergency Clinical Hospital
Bistriţa, Romania
Not Yet Recruiting
73
Coltea Clinical Hospital
Bucharest, Romania
Not Yet Recruiting
74
L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN)
Cluj-Napoca, Romania
Not Yet Recruiting
75
Prof. Dr.Octavian Fodor Regional Institute of Gastroenterology-Hepatology
Cluj-Napoca, Romania
Not Yet Recruiting
76
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Not Yet Recruiting
77
Hospital Clinic Barcelona
Barcelona, Spain
Not Yet Recruiting
78
HUGC Doctor Negrin
LAS Palmas de GC, Spain
Not Yet Recruiting
79
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
80
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Spain
Not Yet Recruiting
81
Althaia Foundation. Hospital Sant Joan de Deu de Manresa
Manresa, Spain
Not Yet Recruiting
82
Hospital Universitario Virgen del Rocío
Seville, Spain
Not Yet Recruiting
83
University Hospital Inselspital Bern
Bern, Switzerland
Not Yet Recruiting
84
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Not Yet Recruiting
85
Epatocentro Ticino
Lugano, Switzerland
Not Yet Recruiting
86
Royal Victoria Hospital
Belfast, United Kingdom
Not Yet Recruiting
87
University Hospitals Bristol and Weston NHS trust, Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Not Yet Recruiting
88
Royal Liverpool University Hospital
Liverpool, United Kingdom
Not Yet Recruiting
89
King's College Hospital
London, United Kingdom
Not Yet Recruiting
90
St Thomas Hospital
London, United Kingdom
Not Yet Recruiting
91
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Not Yet Recruiting
92
Nottingham University Hospitals City Campus
Nottingham, United Kingdom
Not Yet Recruiting
93
John Radcliffe Hospital - Oxford University Hospitals NHS
Oxford, United Kingdom
Not Yet Recruiting
94
Derriford Hospital
Plymouth, United Kingdom
Not Yet Recruiting
95
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Not Yet Recruiting
96
South Warwickshire University Foundation Trust
Warwick, United Kingdom
Not Yet Recruiting
Research Team
T
Trial Registration Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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