NCT05611528CompletedPhase 3
Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia
Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia in a Real Life Setting in Canada
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
This is an open-label study designed to evaluate the long-term safety and efficacy of evinacumab, a fully human ANGPTL3 antibody, in patients with homozygous familial hypercholesterolemia (HoFH), in a real-life setting in Canada. Eligible patients for this study are male and female adult patients with HoFH. Evinacumab will be added on top of the patient's background lipid-modifying therapy (LMT), including statins, ezetimibe, PCSK9 inhibitors, lomitapide or other lipid lowering therapies. This study will be conducted using an hybrid (on-site, foldable sites) approach. Patients will enter the current study, in an open-label treatment period, following their screening. This study will continue until reimbursement of evinacumab in Canada or for a maximum of 24 months. The end of study (EoS) visit will be scheduled 4 weeks after the last dose has been injected and will be followed by a 52-week follow-up.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 31 Oct 2022
- Start date
- 21 Feb 2023
- Primary completion date
- 27 Dec 2024
- Lead sponsor
- Daniel Gaudet
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05611528
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 10
- From 21 Feb 2023 to the primary completion date, 27 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug.
Other illness
- Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study;
Other
- Pregnant or breastfeeding women;
Who the study is looking for
- HoFH patients having been previously or being currently treated with evinacumab or clinical diagnosis of HoFH requiring additional lipid lowering therapy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ecogene-21 Coordinator of this site? Confirm its status | Saguenay | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.