Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07332091

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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

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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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Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis | DecenTrialz