Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)

Completed · Phase 3

Conditions studied: Familial Hypercholesterolemia

In brief

The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.

Key facts

Study ID

NCT02624869

Run by

Amgen

People needed

163

Starts

2016-09-10

Expected to finish

2021-06-01

Last updated by the study team

2024-05-29

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Heterozygous Familial Hypercholesterolemia (HeFH):
• 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 qualify 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

Where it is running

• Research Site — The Bronx, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Camperdown, New South Wales, Australia
• Research Site — Feldkirch, Austria
• Research Site — Salzburg, Austria
• Research Site — Vienna, Austria
• Research Site — Ghent, Belgium
• Research Site — La Louvière, Belgium
• Research Site — Leuven, Belgium
• Research Site — Fortaleza, Ceará, Brazil
• Research Site — Brasília, Federal District, Brazil
• Research Site — São Paulo, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Chicoutimi, Quebec, Canada
• Research Site — Chicoutimi, Quebec, Canada
• Research Site — Québec, Quebec, Canada
• Research Site — Barranquilla, Atlántico, Colombia
• Research Site — Bucaramanga, Santander Department, Colombia
• Research Site — Svitavy, Czechia
• Research Site — Athens, Greece
• Research Site — Thessaloniki, Greece
• Research Site — Budapest, Hungary
• Research Site — Palermo, Italy
• Research Site — Pisa, Italy

Full record on ClinicalTrials.gov

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