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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