Status:
COMPLETED
Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Key
- Completion of the parent study in which they participated
- Able to understand and complete study-related questionnaires
- Key
Exclusion
- Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient
- Concomitant medications that have not been stable prior to the baseline visit
- Adverse event leading to permanent discontinuation from parent study
- 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
- Member of the clinical site study team and/or his/her immediate family
- Pregnant or breastfeeding women
- 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
- 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
Key Trial Info
Start Date :
March 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03409744
Start Date
March 13 2018
End Date
April 13 2023
Last Update
April 8 2025
Active Locations (38)
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1
Clinical Trial Site
Los Angeles, California, United States, 90048
2
Clinical Trial Site
Boca Raton, Florida, United States, 33434
3
Clinical Trial Site
Boston, Massachusetts, United States, 02114
4
Clinical Trial Site
New York, New York, United States, 10029