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)
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)
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.
Inclusion Criteria:
Adult (≥ 18 years) and has provided written informed consent.
Confirmed diagnosis of HFE-HH in medical history.
Evidence of iron overload as shown by:
Body mass index between 18.5 and 34.9 kilograms per meter squared (kg/m^2).
Exclusion Criteria:
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San Diego, California 92123, United States
Indianapolis, Indiana 46202-5149, United States
Baltimore, Maryland 21205, United States
Bethesda, Maryland 20817, United States
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Chapel Hill, North Carolina 27517-7518, United States
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