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

NCT03409744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-04-08

Study results available
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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

DRUG

evinacumab

Intravenous (IV) administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-13
Primary Completion
2023-04-13
Completion
2023-04-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • France
  • Greece
  • Italy
  • Japan
  • Netherlands
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409744 on ClinicalTrials.gov