Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hyp… (NCT03409744) | Clinical Trial Compass
CompletedPhase 3
Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
United States116 participantsStarted 2018-03-13
Plain-language 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
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Completion of the parent study in which they participated
✓. Able to understand and complete study-related questionnaires
Exclusion criteria
✕. 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
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216
✕. 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.