NCT03409744

Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the study are: * To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH) * To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH The secondary objectives of the study are: * To evaluate the effect of evinacumab on lipid parameters in patients with HoFH * To evaluate the effect of evinacumab on lipid parameters in adolescent patients with HoFH * To evaluate the potential development of anti-evinacumab antibodies

Conditions

• Homozygous Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	evinacumab	Intravenous (IV) administration

Timeline

• Start date: 2018-03-13
• Primary completion: 2023-04-13
• Completion: 2023-04-13
• First posted: 2018-01-24
• Last updated: 2025-04-08
• Results posted: 2024-04-30

Locations

38 sites across 12 countries: United States, Australia, Austria, Canada, Czechia, France, Greece, Italy, Japan, Netherlands, South Africa, Ukraine

Regulatory

• FDA-regulated drug study