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 |
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.
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials