Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
- Conditions
- Homozygous Familial Hypercholesterolemia
- Registration Number
- JPRN-jRCT2080224823
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 100
1. Male and female patients >=18 years of age with a diagnosis of functional HoFH.
2. Completion of the 1629 parent study in which they participated (if applicable)
3. Willing and able to comply with clinic visits and study-related procedures.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Incidence and severity of treatment-emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method efficacy<br>1. Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) over time<br>2. Absolute change in LDL-C over time<br>3. Percent change in Apolipoprotein B (ApoB) over time<br>4. Absolute change in ApoB over time<br>5. Percent change in non-High Density Lipoprotein Cholesterol (non-HDL-C) over time<br>6. Absolute change in non-HDL-C over time<br>7. Percent change in Total Cholesterol (TC) over time<br>8. Absolute change in TC over time<br>9. Percent change in Triglycerides (Tg) over time<br>10. Absolute change in Tg over time<br>11. Presence of anti-evinacumab antibodies