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Efficacy and Safety of Vamife...

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

NCT ID: NCT07332091

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-08

Study Completion Date

2028-04-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is multicenter, randomized, placebo-controlled double-blind, parallel-group study.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vamifeport Low Dose

Participants will receive a low dose of vamifeport orally, twice daily (BID) up to Day 360.

Group Type EXPERIMENTAL

Vamifeport

Intervention Type DRUG

Vamifeport capsule administered orally.

Vamifeport High Dose

Participants will receive a high dose of vamifeport orally, BID up to Day 360.

Group Type EXPERIMENTAL

Vamifeport

Intervention Type DRUG

Vamifeport capsule administered orally.

Placebo

Participants will receive placebo matching vamifeport low and high doses orally, BID up to Day 360.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule matching IP administered orally.

Interventions

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Vamifeport

Vamifeport capsule administered orally.

Intervention Type DRUG

Placebo

Placebo capsule matching IP administered orally.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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