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Vamifeport for adults with HFE-related hereditary hemochromatosis

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)

Phase 2 Interventional CSL Behring · NCT07332091

This trial tests whether the oral drug vamifeport can lower liver iron in adults with HFE-related hereditary hemochromatosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment84 (estimated)
Ages18 Years and up
SexAll
SponsorCSL Behring Industry-sponsored
Locations96 sites (Gilbert, Arizona and 95 other locations)
Trial IDNCT07332091 on ClinicalTrials.gov

What this trial studies

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group proof-of-concept trial testing vamifeport versus placebo in adults with HFE-related hereditary hemochromatosis. Participants must have confirmed HFE-HH and evidence of iron overload defined by TSAT >45%, serum ferritin 200–5000 ng/mL, and MRI-measured liver iron concentration (LIC) between 3 and 16 mg/g dry weight. The primary outcome is the effect of vamifeport on MRI-based LIC. Study sites are in Arizona and California and participants are randomized to receive vamifeport or matching placebo under blinded conditions.

Who should consider this trial

Good fit: Adults (≥18 years) with confirmed HFE-related hereditary hemochromatosis, documented iron overload (TSAT >45% confirmed, ferritin 200–5000 ng/mL, and MRI LIC 3–16 mg/g), and BMI 18.5–32 kg/m² are the intended participants.

Not a fit: People with non-HFE forms of iron overload, MRI LIC outside 3–16 mg/g, significant laboratory or ECG abnormalities, major comorbidities, or BMI outside 18.5–32 kg/m² are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, vamifeport could reduce liver iron levels and potentially lessen the need for repeated phlebotomy and downstream iron-related organ damage.

How similar studies have performed: Ferroportin inhibition is a relatively new approach; early-phase and preclinical studies of vamifeport and related agents have shown promising reductions in iron measures but large-scale clinical proof of long-term benefit is still limited.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Gilbert, Arizona and 95 other locations

+46 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Homeostatic Iron Regulator Gene-related Hereditary HemochromatosisSmall Molecule Ferroportin InhibitorHereditary hemochromatosisIron overload
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.