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

Regeneron Pharmaceuticals116 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Completion of the parent study in which they participated 2. Able to understand and complete study-related questionnaires Key Exclusion Criteria: 1. Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient 2. Concomitant medications that have not been stable prior to the baseline visit 3. Adverse event leading to permanent discontinuation from parent study 4. 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 5. Member of the clinical site study team and/or his/her immediate family 6. Pregnant or breastfeeding women 7. 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 8. Men who are sexually active with women of childbearing potential and are unwilling to use the following forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug: vasectomy with medical assessment of surgical success OR consistent use of a condom. Note: Other protocol defined Inclusion/Exclusion criteria apply

Locations (38)

Clinical Trial Site

Los Angeles, California, United States

Clinical Trial Site

Boca Raton, Florida, United States

Clinical Trial Site

Boston, Massachusetts, United States

Clinical Trial Site

New York, New York, United States

Clinical Trial Site

Cincinnati, Ohio, United States

Clinical Trial Site