Trials / Recruiting
RecruitingNCT07332091
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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-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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vamifeport | Vamifeport capsule administered orally. |
| DRUG | Placebo | Placebo capsule matching IP administered orally. |
Timeline
- Start date
- 2026-01-22
- Primary completion
- 2028-03-06
- Completion
- 2028-04-06
- First posted
- 2026-01-12
- Last updated
- 2026-03-27
Locations
96 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Ireland, Italy, Netherlands, New Zealand, Poland, Romania, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07332091. Inclusion in this directory is not an endorsement.