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

NCT07332091

RecruitingPhase 2

Sponsor: CSL Behring

Conditions: Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis

Interventions: Vamifeport, Placebo

Countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 2.4 and 16 mg/g (43.0 and 286.5 mmol/kg) dry weight (dw) at Screening.
* Body mass index between 18.5 and 34.9 kilograms per meter squared (kg/m\^2).

Exclusion Criteria:

* Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.
Locations (99)
  • Gilbert, Arizona, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Jacksonville, Florida, United States
  • Indianapolis, Indiana, United States
  • Baton Rouge, Louisiana, United States
  • Baltimore, Maryland, United States
  • Bethesda, Maryland, United States
  • Frederick, Maryland, United States
  • Ann Arbor, Michigan, United States
  • Duluth, Minnesota, United States
  • Flemington, New Jersey, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Oklahoma City, Oklahoma, United States
  • York, Pennsylvania, United States
  • Murray, Utah, United States
  • Seattle, Washington, United States
  • Spokane, Washington, United States
  • Brisbane, Australia
  • Chandler, Australia
  • Clayton, Australia
  • Perth, Australia
  • Westmead, Australia
  • Innsbruck, Austria
  • Linz, Austria
  • Vienna, Austria
  • Edegem, Belgium
  • Ghent, Belgium
  • Jette, Belgium
  • + 69 more on CT.gov