Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-04-15 @ 12:55 PM
Study NCT ID:
NCT02624869
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D000090542', 'term': 'Homozygous Familial Hypercholesterolemia'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577155', 'term': 'evolocumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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.', 'description': 'Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 27, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 45, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Attention deficit hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arteriovenous fistula aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anorexia nervosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'OG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}, {'id': 'OG002', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'title': 'Any treatment-emergent adverse event (TEAE)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'TEAE ≥ Grade 2', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'TEAE ≥ Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'TEAE ≥ Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to discontinuation of evolocumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fatal adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '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.', 'description': 'An adverse event is defined as any untoward medical occurrence in a clinical trial participant, not necessarily having a causal relationship with study treatment.\n\nA serious AE is as an AE that met at least 1 of the following criteria:\n\n* fatal;\n* life threatening;\n* required in-patient hospitalization or prolongation of existing hospitalization;\n* resulted in persistent or significant disability/incapacity;\n* congenital anomaly/birth defect;\n* other medically important serious event.\n\nAEs were graded for severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0:\n\nGrade 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HeFH Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'OG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.01', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '-34.96', 'spread': '3.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value of the parent study 20120123.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HoFH Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.29', 'groupId': 'OG000', 'lowerLimit': '-40.61', 'upperLimit': '3.54'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and week 80', 'description': 'For HoFH participants baseline was defined as the baseline value in this study (20120124).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 80 in Non-HDL-C in HeFH Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'OG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.37', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '-31.95', 'spread': '2.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value of the parent study 20120123.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 80 in Non-HDL-C in HoFH Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.03', 'groupId': 'OG000', 'lowerLimit': '-40.68', 'upperLimit': '2.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and week 80', 'description': 'For HoFH participants baseline was defined as the baseline value in this study (20120124).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 80 in Apolipoprotein B in HeFH Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'OG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.10', 'spread': '3.32', 'groupId': 'OG000'}, {'value': '-24.15', 'spread': '2.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value in the parent study 20120123.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 80 in Apolipoprotein B in HoFH Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.17', 'groupId': 'OG000', 'lowerLimit': '-33.33', 'upperLimit': '11.59'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and week 80', 'description': 'For HoFH participants baseline was defined as the baseline value in this study (20120124).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HeFH Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'OG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'categories': [{'measurements': 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For HoFH participants baseline was defined as the baseline value in this study (20120124).', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 80 in Dehydroepiandrosterone Sulfate (DHEA-S) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'OG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}, {'id': 'OG002', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.051', 'spread': '0.222', 'groupId': 'OG000'}, {'value': '0.956', 'spread': '0.126', 'groupId': 'OG001'}, {'value': '0.944', 'spread': '0.247', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value in the parent study 20120123. 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'OG000'}, {'value': '2.0', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Females: Change at week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Females: Change at week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Males: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '158.2', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '163.7', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '158.9', 'spread': '4.8', 'groupId': 'OG002'}]}]}, {'title': 'Males: Change at week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Males: Change at week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Males: Change at week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 24, 48, and 80', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight at Weeks 24, 48, and 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'OG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}, {'id': 'OG002', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'title': 'Females: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.8', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '57.0', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '42.7', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Females: Change at week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Females: Change at week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '5.3', 'groupId': 'OG002'}]}]}, {'title': 'Females: Change at week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Males: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.1', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '51.7', 'spread': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Males: Change at week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Males: Change at week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Males: Change at week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 24, 48, and 80', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Tanner Staging From Baseline to Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'OG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}, {'id': 'OG002', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'classes': [{'title': 'Males: Staging by genital size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Males: Staging by pubic hair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Females: Staging by breast development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Females: Staging by pubic hair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and week 80', 'description': '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.\n\nThe number of participants with any change in Tanner Stage from baseline is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with heterozygous familial hypercholesterolemia (HeFH) who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'FG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}, {'id': 'FG002', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 46 centers in 23 countries (Australia, Austria, Belgium, Brazil, Canada, Colombia, Czech Republic, Greece, Hungary, Italy, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom, and United States of America).', 'preAssignmentDetails': 'This study enrolled participants with heterozygous familial hypercholesterolemia (HeFH) who had completed the parent study 20120123 (NCT02392559) without experiencing a treatment-related serious adverse event, and children 10 to 17 years of age with a diagnosis of homozygous familial hypercholesterolemia (HoFH).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'HeFH (Placebo in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.'}, {'id': 'BG001', 'title': 'HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM', 'description': 'Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}, {'id': 'BG002', 'title': 'HoFH: Evolocumab 420 mg QM', 'description': 'Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13.8', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '14.2', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '12.4', 'spread': '2.0', 'groupId': 'BG002'}, {'value': '14.0', 'spread': '2.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'title': '2 - 11 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': '12 - 17 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}, {'title': '18 - 64 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eight HeFH participants were 18 years old at the time of rollover into Study 20120124, however all were ≤ 17 years old at the time of enrollment into the parent study 20120123.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'title': 'North America', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Europe', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': 'Latin America', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Asia Pacific', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low-density Lipoprotein Cholesterol (LDL-C) Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '184.0', 'spread': '48.3', 'groupId': 'BG000'}, {'value': '184.4', 'spread': '45.2', 'groupId': 'BG001'}, {'value': '426.0', 'spread': '166.4', 'groupId': 'BG002'}, {'value': '202.2', 'spread': '88.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'For participants with HeFH who rolled over from parent study 20120123, baseline values are defined as parent study baseline concentrations; for de novo participants with HoFH, baseline values are defined as the mean of the two most recent non-missing concentrations measured through the central laboratory prior to or on Study Day 1.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The full analysis set included all participants with HeFH from parent Study 20120123 who were enrolled and dosed as well as all participants with HoFH who were enrolled and dosed in this study.'}, {'title': 'Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '201.0', 'spread': '49.3', 'groupId': 'BG000'}, {'value': '203.4', 'spread': '47.5', 'groupId': 'BG001'}, {'value': '443.7', 'spread': '170.8', 'groupId': 'BG002'}, {'value': '220.5', 'spread': '90.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'For participants with HeFH who rolled over from parent study 20120123, baseline values are defined as parent study baseline concentrations; for de novo participants with HoFH, baseline values are defined as the mean of the two most recent non-missing concentrations measured through the central laboratory prior to or on Study Day 1.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set'}, {'title': 'Apolipoprotein B (ApoB) Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '119.1', 'spread': '28.1', 'groupId': 'BG000'}, {'value': '123.1', 'spread': '27.4', 'groupId': 'BG001'}, {'value': '250.1', 'spread': '84.9', 'groupId': 'BG002'}, {'value': '131.5', 'spread': '48.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'For participants with HeFH who rolled over from parent study 20120123, baseline values are defined as parent study baseline concentrations; for de novo participants with HoFH, baseline values are defined as the mean of the two most recent non-missing concentrations measured through the central laboratory prior to or on Study Day 1.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set with available baseline data'}, {'title': 'Total Cholesterol/High-density Lipoprotein Cholesterol (HDL-C) Ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.546', 'spread': '1.541', 'groupId': 'BG000'}, {'value': '5.716', 'spread': '1.809', 'groupId': 'BG001'}, {'value': '14.707', 'spread': '7.891', 'groupId': 'BG002'}, {'value': '6.331', 'spread': '3.557', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'For participants with HeFH who rolled over from parent study 20120123, baseline values are defined as parent study baseline concentrations; for de novo participants with HoFH, baseline values are defined as the mean of the two most recent non-missing concentrations measured through the central laboratory prior to or on Study Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set with available baseline data'}, {'title': 'Apolipoprotein B/Apolipoprotein A1 Ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.943', 'spread': '0.265', 'groupId': 'BG000'}, {'value': '0.972', 'spread': '0.306', 'groupId': 'BG001'}, {'value': '2.388', 'spread': '1.036', 'groupId': 'BG002'}, {'value': '1.070', 'spread': '0.545', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'For participants with HeFH who rolled over from parent study 20120123, baseline values are defined as parent study baseline concentrations; for de novo participants with HoFH, baseline values are defined as the mean of the two most recent non-missing concentrations measured through the central laboratory prior to or on Study Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set with available baseline data'}], 'populationDescription': 'All enrolled participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-27', 'size': 1467178, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-16T13:03', 'hasProtocol': True}, {'date': '2020-05-29', 'size': 376870, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-15T08:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2015-10-22', 'resultsFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2015-12-04', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-16', 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': '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.', 'description': 'An adverse event is defined as any untoward medical occurrence in a clinical trial participant, not necessarily having a causal relationship with study treatment.\n\nA serious AE is as an AE that met at least 1 of the following criteria:\n\n* fatal;\n* life threatening;\n* required in-patient hospitalization or prolongation of existing hospitalization;\n* resulted in persistent or significant disability/incapacity;\n* congenital anomaly/birth defect;\n* other medically important serious event.\n\nAEs were graded for severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0:\n\nGrade 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.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HeFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value of the parent study 20120123.'}, {'measure': 'Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HoFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HoFH participants baseline was defined as the baseline value in this study (20120124).'}, {'measure': 'Percent Change From Baseline to Week 80 in Non-HDL-C in HeFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value of the parent study 20120123.'}, {'measure': 'Percent Change From Baseline to Week 80 in Non-HDL-C in HoFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HoFH participants baseline was defined as the baseline value in this study (20120124).'}, {'measure': 'Percent Change From Baseline to Week 80 in Apolipoprotein B in HeFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value in the parent study 20120123.'}, {'measure': 'Percent Change From Baseline to Week 80 in Apolipoprotein B in HoFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HoFH participants baseline was defined as the baseline value in this study (20120124).'}, {'measure': 'Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HeFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value in the parent study 20120123.'}, {'measure': 'Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HoFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HoFH participants baseline was defined as the baseline value in this study (20120124).'}, {'measure': 'Percent Change From Baseline to Week 80 in Apolipoprotein B / Apolipoprotein A1 Ratio in HeFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value in the parent study 20120123.'}, {'measure': 'Percent Change From Baseline to Week 80 in Apolipoprotein B/Apolipoprotein A1 Ratio in HoFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HoFH participants baseline was defined as the baseline value in this study (20120124).'}, {'measure': 'Change From Baseline to Week 80 in LDL-C in HeFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HeFH participants baseline was defined as the baseline value of the parent study 20120123.'}, {'measure': 'Change From Baseline to Week 80 in LDL-C in HoFH Participants', 'timeFrame': 'Baseline and week 80', 'description': 'For HoFH participants baseline was defined as the baseline value in this study (20120124).'}, {'measure': 'Change From Baseline to Week 80 in Estradiol Levels', 'timeFrame': 'Baseline and week 80', '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).'}, {'measure': 'Change From Baseline to Week 80 in Testosterone Levels', 'timeFrame': 'Baseline and week 80', '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).'}, {'measure': 'Change From Baseline to Week 80 in Follicle Stimulating Hormone (FSH) Levels', 'timeFrame': 'Baseline and week 80', '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).'}, {'measure': 'Change From Baseline to Week 80 in Luteinizing Hormone (LH) Levels', 'timeFrame': 'Baseline and week 80', '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).'}, {'measure': 'Change From Baseline to Week 80 in Adenocorticotropic Hormone (ACTH) Levels', 'timeFrame': 'Baseline and week 80', '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).'}, {'measure': 'Change From Baseline to Week 80 in Dehydroepiandrosterone Sulfate (DHEA-S) Levels', 'timeFrame': 'Baseline and week 80', '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).'}, {'measure': 'Change From Baseline to Week 80 in Cortisol Levels', 'timeFrame': 'Baseline and week 80', '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).'}, {'measure': 'Number of Participants With Liver Function Test Abnormalities at Week 80', 'timeFrame': 'Week 80', 'description': 'Liver function tests included alanine aminotransferase (ALT) levels, aspartate aminotransferase (AST) levels and total bilirubin levels.'}, {'measure': 'Number of Participants With Abnormalities in Levels of Creatine Kinase (CK) at Week 80', 'timeFrame': '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.'}, {'measure': 'Change From Baseline to Week 80 in Carotid Intima-media Thickness (cIMT)', 'timeFrame': 'Baseline and week 80', 'description': '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.\n\nCIMT 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.'}, {'measure': 'Change From Baseline in Height at Weeks 24, 48, and 80', 'timeFrame': 'Baseline and weeks 24, 48, and 80'}, {'measure': 'Change From Baseline in Weight at Weeks 24, 48, and 80', 'timeFrame': 'Baseline and weeks 24, 48, and 80'}, {'measure': 'Number of Participants With Change in Tanner Staging From Baseline to Week 80', 'timeFrame': 'Baseline and week 80', 'description': '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.\n\nThe number of participants with any change in Tanner Stage from baseline is reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypercholesterolemia', 'Elevated Cholesterol', 'High Cholesterol', 'PCSK9 mutations', 'Severe Familial Hypercholesterolemia', 'evolocumab', 'Repatha', 'Heterozygous Familial Hypercholesterolemia', 'Homozygous Familial Hypercholesterolemia', 'Pediatric', 'Paediatric'], 'conditions': ['Familial Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '36075246', 'type': 'BACKGROUND', '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.'}, {'pmid': '38545781', 'type': 'BACKGROUND', 'citation': 'Raal FJ, Hegele RA, Ruzza A, Lopez JAG, Bhatia AK, Wu J, Wang H, Gaudet D, Wiegman A, Wang J, Santos RD. Evolocumab Treatment in Pediatric Patients With Homozygous Familial Hypercholesterolemia: Pooled Data From Three Open-Label Studies. Arterioscler Thromb Vasc Biol. 2024 May;44(5):1156-1164. doi: 10.1161/ATVBAHA.123.320268. Epub 2024 Mar 28.'}, {'pmid': '37855448', 'type': 'BACKGROUND', 'citation': 'Santos RD, Ruzza A, Wang B, Maruff P, Schembri A, Bhatia AK, Mach F, Bergeron J, Gaudet I, St Pierre J, Kastelein JJP, Hovingh GK, Wiegman A, Gaudet D, Raal FJ. Evolocumab in paediatric heterozygous familial hypercholesterolaemia: cognitive function during 80 weeks of open-label extension treatment. Eur J Prev Cardiol. 2024 Feb 15;31(3):302-310. doi: 10.1093/eurjpc/zwad332.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHeterozygous Familial Hypercholesterolemia (HeFH):\n\n-Completed Study 20120123 (NCT02392559) while still on assigned investigational product and did not experience a treatment-related serious adverse event\n\nHomozygous Familial Hypercholesterolemia (HoFH):\n\n* Male or female, ≥ 10 to ≤ 17 years of age at time of enrollment\n* Diagnosis of HoFH\n* On a low-fat diet and receiving background lipid-lowering therapy\n* Lipid-lowering therapy unchanged for ≥ 4 weeks prior to LDL-C screening; fibrates must be stable for at least 6 weeks prior to screening.\n* Fasting LDL-C at screening ≥ 130 mg/dL (3.4 mmol/L)\n* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)\n\nExclusion Criteria:\n\n-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\n\nHoFH:\n\n* Moderate to severe renal dysfunction\n* Active liver disease or hepatic dysfunction,\n* Creatine kinase \\> 3 times the upper limit of normal (ULN) at screening'}, 'identificationModule': {'nctId': 'NCT02624869', 'acronym': 'HAUSER-OLE', 'briefTitle': 'Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '20120124'}, 'secondaryIdInfos': [{'id': '2015-002276-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evolocumab', 'description': 'Participants receive 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.', 'interventionNames': ['Biological: Evolocumab']}], 'interventions': [{'name': 'Evolocumab', 'type': 'BIOLOGICAL', 'otherNames': ['Repatha®', 'AMG 145'], 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Evolocumab']}]}, 'contactsLocationsModule': {'locations': 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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.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}