Last updated on December 2019

Open Label Study to Evaluate Safety Tolerability and Efficacy of Evolocumab (AMG 145) in Pediatric Subjects (10 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH).

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: Between 10 - 17 Years
  • Gender: Male or Female

Inclusion Criteria:

Subjects with HeFH:

-Completed Study 20120123 while still on assigned investigational product and did not experience a treatmentrelated serious adverse event

Subjects with 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)

Exclusion Criteria:

All Subjects

-Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treament on another investigational device or drug study(s); except Study 20120123

Subjects with HoFH:

  • Moderate to severe renal dysfunction
  • Active liver disease or hepatic dysfunction,
  • CK > 3 times the ULN at screening

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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