Back to resultsTrial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders (HAUSER-RCT)
Primary Purpose
Heterozygous Familial Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heterozygous Familial Hypercholesterolemia focused on measuring Hypercholesterolemia, Elevated Cholesterol, High Cholesterol, Heterozygous Familial Hypercholesterolemia, PCSK9 mutations, Paediatric, pediatric, Childhood Familial Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥ 10 to ≤ 17 years of age (before 18th birthday)
- Diagnosis of heterozygous familial hypercholesterolemia
- On an approved statin with stable optimized dose for ≥ 4 weeks
- Other lipid-lowering therapy stable for ≥ 4 weeks (fibrates must be stable for ≥ 6 weeks)
- Fasting LDL-C ≥ 130 mg/dL (3.4 mmol/L)
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
- Type 1 diabetes, or type 2 diabetes that is or poorly controlled
- Uncontrolled hyperthyroidism or hypothyroidism
- Cholesterylester transfer protein (CETP) inhibitor in the last 12 months, or mipomersen or lomitapide in the last 5 months
- Previously received evolocumab or any other investigational therapy to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9).
- Lipid apheresis within the last 12 weeks prior to screening.
- Homozygous familial hypercholesterolemia
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
EvoMab 420 mg QM
Arm Description
Matching subcutaneous injection every 4 weeks (QM)
Evolocumab subcutaneous injection QM
Outcomes
Primary Outcome Measures
Percent Change From Baseline to Week 24 in LDL-C
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from interactive voice response system [IVRS]), scheduled visit and the interaction of treatment with scheduled visit as covariates. The model uses an unstructured covariance.
Secondary Outcome Measures
Mean Percent Change From Baseline to Mean of Weeks 22 and 24 in LDL-C
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Change From Baseline to Week 24 in LDL-C
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Percent Change From Baseline to Week 24 in Non-HDL-C
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates
Percent Change From Baseline to Week 24 in Apoliprotein-B (ApoB)
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Percent Change From Baseline to Week 24 in Total Cholesterol/HDL-C Ratio
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Percent Change From Baseline to Week 24 in ApoB:ApoA1 Ratio
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with study treatment. An SAE is defined as an adverse event that: is fatal; is a life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other medically important serious event. Events were graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading scale (1=mild; 2=moderate; 3=severe; 4=life-threatening; 5=death). Events were defined as treatment emergent if they occurred after the first dose of study drug and up to and including 30 days after the last dose or the end of study date, whichever is earlier.
Number of Participants With Maximum Post-Baseline Laboratory Toxicities of Grade ≥ 3
Laboratory toxicity grading was based on NCI CTCAE grading. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity. Values representing a worsening from baseline are shown.
Change From Baseline Over Time in Systolic Blood Pressure
Change From Baseline Over Time in Diastolic Blood Pressure
Change From Baseline Over Time in Heart Rate
Number of Participants Testing Positive for Anti-Evolocumab Antibodies
Serum Evolocumab Concentrations Over Time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02392559
Brief Title
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
Acronym
HAUSER-RCT
Official Title
Double-blind, Randomized, Multicenter, Placebo-Controlled Study to Characterize the Efficacy, Safety, and Tolerability of 24 Weeks of Evolocumab for LDL-C Reduction in Pediatric Subjects 10 to 17 Years of Age With HeFH
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2016 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
Detailed Description
A study to evaluate the effect of 24 weeks of subcutaneous (SC) evolocumab compared with placebo, when added to standard of care, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in pediatric subjects 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterozygous Familial Hypercholesterolemia
Keywords
Hypercholesterolemia, Elevated Cholesterol, High Cholesterol, Heterozygous Familial Hypercholesterolemia, PCSK9 mutations, Paediatric, pediatric, Childhood Familial Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching subcutaneous injection every 4 weeks (QM)
Arm Title
EvoMab 420 mg QM
Arm Type
Experimental
Arm Description
Evolocumab subcutaneous injection QM
Intervention Type
Drug
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145; EvoMab
Intervention Description
Dose of subcutaneous evolocumab every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose of subcutaneous placebo treatment every 4 weeks
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Week 24 in LDL-C
Description
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from interactive voice response system [IVRS]), scheduled visit and the interaction of treatment with scheduled visit as covariates. The model uses an unstructured covariance.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Mean Percent Change From Baseline to Mean of Weeks 22 and 24 in LDL-C
Description
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time Frame
Baseline, Week 22, Week 24
Title
Change From Baseline to Week 24 in LDL-C
Description
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline to Week 24 in Non-HDL-C
Description
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline to Week 24 in Apoliprotein-B (ApoB)
Description
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline to Week 24 in Total Cholesterol/HDL-C Ratio
Description
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline to Week 24 in ApoB:ApoA1 Ratio
Description
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time Frame
Baseline, Week 24
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Description
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with study treatment. An SAE is defined as an adverse event that: is fatal; is a life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other medically important serious event. Events were graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading scale (1=mild; 2=moderate; 3=severe; 4=life-threatening; 5=death). Events were defined as treatment emergent if they occurred after the first dose of study drug and up to and including 30 days after the last dose or the end of study date, whichever is earlier.
Time Frame
From first dose of study drug up to and including 30 days after the last dose or end of study date (Week 24), whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for Placebo and EvoMab arms, respectively.
Title
Number of Participants With Maximum Post-Baseline Laboratory Toxicities of Grade ≥ 3
Description
Laboratory toxicity grading was based on NCI CTCAE grading. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity. Values representing a worsening from baseline are shown.
Time Frame
Week 24
Title
Change From Baseline Over Time in Systolic Blood Pressure
Time Frame
Baseline, Week 4, Week 12, Week 20, Week 22, Week 24
Title
Change From Baseline Over Time in Diastolic Blood Pressure
Time Frame
Baseline, Week 4, Week 12, Week 20, Week 22, Week 24
Title
Change From Baseline Over Time in Heart Rate
Time Frame
Baseline, Week 4, Week 12, Week 20, Week 22, Week 24
Title
Number of Participants Testing Positive for Anti-Evolocumab Antibodies
Time Frame
up to Week 24
Title
Serum Evolocumab Concentrations Over Time
Time Frame
Week 12, Week 22, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 10 to ≤ 17 years of age (before 18th birthday)
Diagnosis of heterozygous familial hypercholesterolemia
On an approved statin with stable optimized dose for ≥ 4 weeks
Other lipid-lowering therapy stable for ≥ 4 weeks (fibrates must be stable for ≥ 6 weeks)
Fasting LDL-C ≥ 130 mg/dL (3.4 mmol/L)
Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
Type 1 diabetes, or type 2 diabetes that is or poorly controlled
Uncontrolled hyperthyroidism or hypothyroidism
Cholesterylester transfer protein (CETP) inhibitor in the last 12 months, or mipomersen or lomitapide in the last 5 months
Previously received evolocumab or any other investigational therapy to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9).
Lipid apheresis within the last 12 weeks prior to screening.
Homozygous familial hypercholesterolemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Research Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Research Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Research Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Research Site
City
Feldkirch
ZIP/Postal Code
6800
Country
Austria
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-270
Country
Brazil
Facility Name
Research Site
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
71625-175
Country
Brazil
Facility Name
Research Site
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04040-000
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Research Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Research Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Research Site
City
Barranquilla
State/Province
Atlántico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Research Site
City
Floridablanca
State/Province
Santander
Country
Colombia
Facility Name
Research Site
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Svitavy
ZIP/Postal Code
568 25
Country
Czechia
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Research Site
City
Kuopio
ZIP/Postal Code
70029
Country
Finland
Facility Name
Research Site
City
Athens
ZIP/Postal Code
17674
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Research Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Research Site
City
Oslo
ZIP/Postal Code
0586
Country
Norway
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125412
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
Research Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Research Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0087
Country
South Africa
Facility Name
Research Site
City
Parow
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Research Site
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
A Coruña
State/Province
Galicia
ZIP/Postal Code
15001
Country
Spain
Facility Name
Research Site
City
Lugo
State/Province
Galicia
ZIP/Postal Code
27003
Country
Spain
Facility Name
Research Site
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Research Site
City
Reinach
ZIP/Postal Code
4153
Country
Switzerland
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
IPD Sharing URL
https://www.amgen.com/datasharing
Citations:
PubMed Identifier
32865373
Citation
Santos RD, Ruzza A, Hovingh GK, Wiegman A, Mach F, Kurtz CE, Hamer A, Bridges I, Bartuli A, Bergeron J, Szamosi T, Santra S, Stefanutti C, Descamps OS, Greber-Platzer S, Luirink I, Kastelein JJP, Gaudet D; HAUSER-RCT Investigators. Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020 Oct 1;383(14):1317-1327. doi: 10.1056/NEJMoa2019910. Epub 2020 Aug 29.
Results Reference
background
PubMed Identifier
30318065
Citation
Gaudet D, Langslet G, Gidding SS, Luirink IK, Ruzza A, Kurtz C, Lu C, Somaratne R, Raal FJ, Wiegman A. Efficacy, safety, and tolerability of evolocumab in pediatric patients with heterozygous familial hypercholesterolemia: Rationale and design of the HAUSER-RCT study. J Clin Lipidol. 2018 Sep-Oct;12(5):1199-1207. doi: 10.1016/j.jacl.2018.05.007. Epub 2018 May 22.
Results Reference
background
PubMed Identifier
36210291
Citation
Gaudet D, Ruzza A, Bridges I, Maruff P, Schembri A, Hamer A, Mach F, Bergeron J, Gaudet I, Pierre JS, Kastelein JJP, Hovingh GK, Wiegman A, Raal FJ, Santos RD. Cognitive function with evolocumab in pediatric heterozygous familial hypercholesterolemia. J Clin Lipidol. 2022 Sep-Oct;16(5):676-684. doi: 10.1016/j.jacl.2022.07.005. Epub 2022 Jul 21.
Results Reference
background
PubMed Identifier
33078867
Citation
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
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