Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
Completed Study 20120123 (NCT02392559) while still on assigned investigational product and did not experience a treatment-related serious adverse event
Homozygous Familial Hypercholesterolemia (HoFH):
Male or female, ≥ 10 to ≤ 17 years of age at time of enrollment
Diagnosis of HoFH
On a low-fat diet and receiving background lipid-lowering therapy
Lipid-lowering therapy unchanged for ≥ 4 weeks prior to LDL-C screening; fibrates must be stable for at least 6 weeks prior to screening.
Fasting LDL-C at screening ≥ 130 mg/dL (3.4 mmol/L)
Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
You may not be if
Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s); except Study 20120123
HoFH:
Moderate to severe renal dysfunction
Active liver disease or hepatic dysfunction,
Creatine kinase \> 3 times the upper limit of normal (ULN) at screening
