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



Status:Enrolling by invitation
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:12 - Any
Updated:3/30/2019
Start Date:March 13, 2018
End Date:April 11, 2022

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

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


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. Sexually active men who are unwilling to use forms of medically acceptable birth
control during the study drug treatment period and for 24 weeks after the last
injection of study drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
7
sites
8041 Hosbrook Road
Cincinnati, Ohio 45236
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Boca Raton, Florida 33434
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Boston, Massachusetts 02114
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Chicoutimi, Quebec
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Dallas, Texas 75390
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Los Angeles, California 90033
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Los Angeles, CA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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