Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
In brief
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.
Key facts
- Study ID
- NCT07332091
- Run by
- CSL Behring
- People needed
- 84
- Starts
- 2026-01-22
- Expected to finish
- 2028-04-06
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- CHU Toulouse — Toulouse, France (enrolling)
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
- CHU de Montpellier- Hôpital Saint Eloi — Montpellier, France (enrolling)
- Centre Hospitalier de Saint Brieuc — Saint-Brieuc, France (enrolling)
- EUGASTRO GmbH — Leipzig, Germany (enrolling)
- MVZ für Innere Medizin Weinheim — Weinheim, Germany (enrolling)
- CRMR Maladies du Globule Rouge, Hôpital de la Timone — Marseille, France (enrolling)
- James M. Stockman Cancer Institute — Frederick, Maryland, United States (enrolling)
- Centre Hospitalier Lyon Sud/Hospices Civils de Lyon — Pierre-Bénite, France (enrolling)
- Chu Rennes — Rennes, France (enrolling)
- University Hospital Heidelberg — Heidelberg, Germany (enrolling)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Duke University Medical Center (Duke South Clinics) -40 Duke Medicine Cir — Durham, North Carolina, United States (enrolling)
- Hightower Clinical - Oklahoma Cancer Center — Oklahoma City, Oklahoma, United States (enrolling)
- American Oncology Partners, PA dba The Center for Cancer and Blood Disorders — Bethesda, Maryland, United States (enrolling)
- Green Leaf Clinical Trials — Jacksonville, Florida, United States (enrolling)
- Velocity Clinical Research-Seattle — Seattle, Washington, United States (enrolling)
- Washington State Univ Elson S. Floyd College of Medicine — Spokane, Washington, United States (enrolling)
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (enrolling)
- CHU de Bordeaux - Hôpital Haut Leveque — Pessac, France (enrolling)
- Aspirus St. Luke's Clinic - Duluth - Oncology & Hematology — Duluth, Minnesota, United States (enrolling)
- Trials West — Perth, Australia (enrolling)
- Ochsner Medical Complex - High Grove — Baton Rouge, Louisiana, United States (enrolling)
- Hôpital Paul Brousse — Villejuif, France (enrolling)
- University of Verona - Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy (enrolling)
Full record on ClinicalTrials.gov
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