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Recruiting NCT07332091

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

Conditions: Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 84
Sponsor: CSL Behring

Location: Banner MD Anderson Gilbert Arizona

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 Criteria

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 2.4 and 16 mg/g (43.0 and 286.5 mmol/kg) dry weight (dw) at Screening. * Body mass index between 18.5 and 34.9 kilograms per meter squared (kg/m\^2). Exclusion Criteria: * Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07332091). StuddyBuddy aggregates publicly available trial information.