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.

CT.gov Identifier
NCT07332091
EudraCT Identifier
N/A
CTIS:
2025-523793-16-00
Sponsor
CSL Behring
Collaborator
N/A
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Alport syndrome
Study Drug
Bupropion & Placebo
See More
Tramadol Hydrochloride & Placebo
Placebo
Placebo & Placebo
Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks
Magnesium sulphate & Placebo
Pregabalin & Placebo
Vamifeport
Placebo; 0.9% saline
Phase 2; Placebo
Phase 3; Placebo
Placebo; oral
HRS-7535;Placebo
Genes
COL4A4
COL4A3
Study Dates
Jan 2026 - Mar 2028
Sex
Ignored
Age
18+ years
Inclusion and Exclusion 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 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).
Exclusion Criteria:
  • Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.

Protocol 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.

Study Locations

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