Vamifeport for Hereditary Hemochromatosis
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Recruiting
Phase 2
Interventional Study
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 84 (estimated)
- Sponsor
- CSL Behring · Industry
Who this trial is looking for
This trial is looking for adults with a specific type of hereditary hemochromatosis. Participants will take a treatment called vamifeport and have their liver iron levels checked through MRI scans.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have been diagnosed with hereditary hemochromatosis.
- I have evidence of iron overload.
- My body mass index is between 18.5 and 32.
You may not be able to join if
- I have clinically relevant laboratory abnormalities or ECG findings.
- I have a medical history that is relevant.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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…
Trial Locations
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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 m…
Contacts