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)
CSL Behring
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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: * 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…
Interventions
- DrugVamifeport
Vamifeport capsule administered orally.
- DrugPlacebo
Placebo capsule matching IP administered orally.
Locations (96)
- Banner MD AndersonGilbert, Arizona
- Infinity Clinical TrialsSan Diego, California
- Medical Oncology Associates of San DiegoSan Diego, California
- Green Leaf Clinical TrialsJacksonville, Florida
- Indiana University Health University HospitalIndianapolis, Indiana
- Ochsner Medical Complex - High GroveBaton Rouge, Louisiana