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

Primary Purpose

Familial Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Evolocumab

About this trial

This is an interventional treatment trial for Familial Hypercholesterolemia focused on measuring Hypercholesterolemia, Elevated Cholesterol, High Cholesterol, PCSK9 mutations, Severe Familial Hypercholesterolemia, evolocumab, Repatha, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia, Pediatric, Paediatric

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evolocumab

Arm Description

Participants receive 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event is defined as any untoward medical occurrence in a clinical trial participant, not necessarily having a causal relationship with study treatment. A serious AE is as an AE that met at least 1 of the following criteria: fatal; life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. AEs were graded for severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death related to AE.

Secondary Outcome Measures

Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HeFH Participants

For HeFH participants baseline was defined as the baseline value of the parent study 20120123.

Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HoFH Participants

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Percent Change From Baseline to Week 80 in Non-HDL-C in HeFH Participants

For HeFH participants baseline was defined as the baseline value of the parent study 20120123.

Percent Change From Baseline to Week 80 in Non-HDL-C in HoFH Participants

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Percent Change From Baseline to Week 80 in Apolipoprotein B in HeFH Participants

For HeFH participants baseline was defined as the baseline value in the parent study 20120123.

Percent Change From Baseline to Week 80 in Apolipoprotein B in HoFH Participants

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HeFH Participants

For HeFH participants baseline was defined as the baseline value in the parent study 20120123.

Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HoFH Participants

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Percent Change From Baseline to Week 80 in Apolipoprotein B / Apolipoprotein A1 Ratio in HeFH Participants

For HeFH participants baseline was defined as the baseline value in the parent study 20120123.

Percent Change From Baseline to Week 80 in Apolipoprotein B/Apolipoprotein A1 Ratio in HoFH Participants

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Change From Baseline to Week 80 in LDL-C in HeFH Participants

For HeFH participants baseline was defined as the baseline value of the parent study 20120123.

Change From Baseline to Week 80 in LDL-C in HoFH Participants

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Change From Baseline to Week 80 in Estradiol Levels

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Change From Baseline to Week 80 in Testosterone Levels

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Change From Baseline to Week 80 in Follicle Stimulating Hormone (FSH) Levels

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Change From Baseline to Week 80 in Luteinizing Hormone (LH) Levels

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Change From Baseline to Week 80 in Adenocorticotropic Hormone (ACTH) Levels

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Change From Baseline to Week 80 in Dehydroepiandrosterone Sulfate (DHEA-S) Levels

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Change From Baseline to Week 80 in Cortisol Levels

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Number of Participants With Liver Function Test Abnormalities at Week 80

Liver function tests included alanine aminotransferase (ALT) levels, aspartate aminotransferase (AST) levels and total bilirubin levels.

Number of Participants With Abnormalities in Levels of Creatine Kinase (CK) at Week 80

The number of participants with levels of creatine kinase greater than 5 times the upper limit of normal (ULN) and greater than 10 times the ULN, measured by the central laboratory.

Change From Baseline to Week 80 in Carotid Intima-media Thickness (cIMT)

Carotid intima-media thickness measures the thickness of the intima and media, the inner two layers of the carotid artery, and is used to determine the extent of plaque buildup in the walls of the arteries (atherosclerosis) supplying blood to the head. CIMT was measured by ultrasonography and analyzed at a core laboratory. The largest values measured in the left common carotid artery (LCCA) and the right common carotid artery (RCCA) are averaged in this analysis.

Change From Baseline in Height at Weeks 24, 48, and 80

Change From Baseline in Weight at Weeks 24, 48, and 80

Number of Participants With Change in Tanner Staging From Baseline to Week 80

Pubertal growth and sexual maturity was assessed separately for males and females using the 5 Tanner stages where stage 1 = prepubertal and stage 5 = mature. The number of participants with any change in Tanner Stage from baseline is reported.

Full Information

NCT ID

NCT02624869

First Posted

October 22, 2015

Last Updated

December 16, 2021

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02624869

Brief Title

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

Acronym

HAUSER-OLE

Official Title

Open-label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

September 10, 2016 (Actual)

Primary Completion Date

June 1, 2021 (Actual)

Study Completion Date

June 1, 2021 (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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Familial Hypercholesterolemia

Keywords

Hypercholesterolemia, Elevated Cholesterol, High Cholesterol, PCSK9 mutations, Severe Familial Hypercholesterolemia, evolocumab, Repatha, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia, Pediatric, Paediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

163 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Evolocumab

Arm Type

Experimental

Arm Description

Participants receive 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.

Intervention Type

Biological

Intervention Name(s)

Evolocumab

Other Intervention Name(s)

Repatha®, AMG 145

Intervention Description

Administered by subcutaneous injection

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks.

Secondary Outcome Measure Information:

Title

Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HeFH Participants

Description

For HeFH participants baseline was defined as the baseline value of the parent study 20120123.

Time Frame

Baseline and week 80

Title

Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HoFH Participants

Description

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Percent Change From Baseline to Week 80 in Non-HDL-C in HeFH Participants

Description

For HeFH participants baseline was defined as the baseline value of the parent study 20120123.

Time Frame

Baseline and week 80

Title

Percent Change From Baseline to Week 80 in Non-HDL-C in HoFH Participants

Description

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Percent Change From Baseline to Week 80 in Apolipoprotein B in HeFH Participants

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123.

Time Frame

Baseline and week 80

Title

Percent Change From Baseline to Week 80 in Apolipoprotein B in HoFH Participants

Description

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HeFH Participants

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123.

Time Frame

Baseline and week 80

Title

Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HoFH Participants

Description

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Percent Change From Baseline to Week 80 in Apolipoprotein B / Apolipoprotein A1 Ratio in HeFH Participants

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123.

Time Frame

Baseline and week 80

Title

Percent Change From Baseline to Week 80 in Apolipoprotein B/Apolipoprotein A1 Ratio in HoFH Participants

Description

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Change From Baseline to Week 80 in LDL-C in HeFH Participants

Description

For HeFH participants baseline was defined as the baseline value of the parent study 20120123.

Time Frame

Baseline and week 80

Title

Change From Baseline to Week 80 in LDL-C in HoFH Participants

Description

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Change From Baseline to Week 80 in Estradiol Levels

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Change From Baseline to Week 80 in Testosterone Levels

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Change From Baseline to Week 80 in Follicle Stimulating Hormone (FSH) Levels

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Change From Baseline to Week 80 in Luteinizing Hormone (LH) Levels

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Change From Baseline to Week 80 in Adenocorticotropic Hormone (ACTH) Levels

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Change From Baseline to Week 80 in Dehydroepiandrosterone Sulfate (DHEA-S) Levels

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Change From Baseline to Week 80 in Cortisol Levels

Description

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Time Frame

Baseline and week 80

Title

Number of Participants With Liver Function Test Abnormalities at Week 80

Description

Liver function tests included alanine aminotransferase (ALT) levels, aspartate aminotransferase (AST) levels and total bilirubin levels.

Time Frame

Week 80

Title

Number of Participants With Abnormalities in Levels of Creatine Kinase (CK) at Week 80

Description

The number of participants with levels of creatine kinase greater than 5 times the upper limit of normal (ULN) and greater than 10 times the ULN, measured by the central laboratory.

Time Frame

Week 80

Title

Change From Baseline to Week 80 in Carotid Intima-media Thickness (cIMT)

Description

Time Frame

Baseline and week 80

Title

Change From Baseline in Height at Weeks 24, 48, and 80

Time Frame

Baseline and weeks 24, 48, and 80

Title

Change From Baseline in Weight at Weeks 24, 48, and 80

Time Frame

Baseline and weeks 24, 48, and 80

Title

Number of Participants With Change in Tanner Staging From Baseline to Week 80

Description

Time Frame

Baseline and week 80

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

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

Gent

ZIP/Postal Code

9000

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

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

Bucaramanga

State/Province

Santander

ZIP/Postal Code

81004

Country

Colombia

Facility Name

Research Site

City

Svitavy

ZIP/Postal Code

568 25

Country

Czechia

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

1066 EC

Country

Netherlands

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

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

Parktown

State/Province

Gauteng

ZIP/Postal Code

2193

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

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

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

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

36075246

Citation

Santos RD, Ruzza A, Hovingh GK, Stefanutti C, Mach F, Descamps OS, Bergeron J, Wang B, Bartuli A, Buonuomo PS, Greber-Platzer S, Luirink I, Bhatia AK, Raal FJ, Kastelein JJP, Wiegman A, Gaudet D. Paediatric patients with heterozygous familial hypercholesterolaemia treated with evolocumab for 80 weeks (HAUSER-OLE): a single-arm, multicentre, open-label extension of HAUSER-RCT. Lancet Diabetes Endocrinol. 2022 Oct;10(10):732-740. doi: 10.1016/S2213-8587(22)00221-2. Epub 2022 Sep 5.

Results Reference

derived

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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

Familial Hypercholesterolemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial