- * 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).
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
NCT07332091 | PHASE 2 | INTERVENTIONAL
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 Information
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Banner MD Anderson
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University of North Carolina at Chapel Hill
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Intermountain Medical Center
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Westmead Hospital for Medical Research
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Ordensklinikum Linz Barmherzige Schwestern
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Universitair Ziekenhuis Antwerpen (UZA)
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McMaster UniversitySt. Josephs Healthcare Hamilton
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Copenhagen University Hospital Hvidovre
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Hospital Clinic Barcelona
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HUGC Doctor Negrin
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Hospital Universitario La Paz
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Study Eligibility Criteria
Additional Studies
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