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Study Complete
Sponsor ID
20120124

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

Sponsor ID
20120124
Clinicaltrials.gov ID
NCT02624869
EUCTIS ID
N/A
EudraCT ID
2015-002276-25
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
163
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of participants with treatment-related Adverse Events as assessed by CTCAE V4.0

Timeframe: 80 weeks

Secondary Outcome Measures

Percent change from baseline in low-density lipoprotein cholesterol (LDL-C)

Timeframe: Week 80

Percent change from baseline in non-HDL-C (non high density lipoprotein cholesterol)

Timeframe: Week 80

Percent change from baseline in apoliprotein-b (ApoB)

Timeframe: Week 80

Percent change from baseline total cholesterol/HDL-C ratio

Timeframe: Week 80

Percent change from baseline ApoB/ApoA1 ratio

Timeframe: Week 80

Change from baseline in LDL-C

Timeframe: Week 80

Change from baseline in steroid hormones

Timeframe: Week 80

Change from baseline in Carotid intima-media thickness (cIMT) at week 80

Timeframe: Week 80

Subject incidence of abnormal muscle enzyme levels

Timeframe: Week 80

Subject incidence of abnormal liver enzyme levels

Timeframe: Week 80

Change from baseline in height

Timeframe: Week 24, 48 and 80

Change from baseline in weight.

Timeframe: Week 24, 48 and 80

Change from baseline in pubertal development

Timeframe: Week 24, 48 and 80

Number of participants with abnormal neurological examination findings

Timeframe: Week 80

Change from baseline score in the components of the Cogstate battery (cognitive function assessments)

Timeframe: Week 24, 48, and 80

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Cincinnati, OH, United States, 45227
Status
Recruiting
Location
Research Site
Gent, Belgium, 9000
Status
Recruiting
Location
Research Site
Parktown, Gauteng, South Africa, 2193
Status
Recruiting
Location
Research Site
Feldkirch, Austria, 6800
Status
Recruiting
Location
Research Site
Wien, Austria, 1090
Status
Recruiting
Location
Research Site
Oslo, Norway, 0586
Status
Recruiting
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Study Info
Age
10 - 17 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Sep 2016 - Jun 2021
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    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)
    Exclusion Criteria:
    -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