Status:

RECRUITING

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

Lead Sponsor:

CSL Behring

Conditions:

Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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-rel...

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 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.

Key Trial Info

Start Date :

January 22 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 6 2028

Estimated Enrollment :

84 Patients enrolled

Trial Details

Trial ID

NCT07332091

Start Date

January 22 2026

End Date

April 6 2028

Last Update

March 27 2026

Active Locations (96)

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Page 1 of 24 (96 locations)

1

Banner MD Anderson

Gilbert, Arizona, United States, 85234-2165

2

Infinity Clinical Trials

San Diego, California, United States, 92108

3

Medical Oncology Associates of San Diego

San Diego, California, United States, 92123

4

Green Leaf Clinical Trials

Jacksonville, Florida, United States, 32258

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