Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
NCT ID: NCT01624142
Last Updated: 2024-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2012-06-01
2018-05-11
Brief Summary
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Detailed Description
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Participants were to continue to receive open-label evolocumab for up to 5 years or until evolocumab became commercially available in the relevant patient population, whichever occurred first.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Evolocumab
Participants received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
Evolocumab
Evolocumab was administered by subcutaneous injection either once a month (QM) or once every two weeks (Q2W).
Interventions
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Evolocumab
Evolocumab was administered by subcutaneous injection either once a month (QM) or once every two weeks (Q2W).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
OR
* Have a diagnosis of familial hypercholesterolemia AND
* Males and females ≥ 12 to ≤ 80 years of age
* Stable low-fat diet and lipid-lowering therapies for at least 4 weeks
* Low-density lipoprotein cholesterol (LDL-C) \>= 130 mg/dl (3.4 mmol/L) for subjects without diagnosed coronary heart disease (CHD)/CHD risk equivalent OR LDL-C \>= 100 mg/dl (2.6 mmol/L) for subjects with diagnosed CHD or CHD risk equivalent OR apheresis patients have no LDL-C entry requirement
* Fasting triglycerides ≤ 400 mg/dL(4.5 mmol/L)
* Body weight of \> 40 kg or greater at screening for subjects less than 18 years of age
Exclusion Criteria
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of screening
* Planned cardiac surgery or revascularization
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
12 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Los Angeles, California, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research Site
Hobart, Tasmania, Australia
Research Site
Perth, Western Australia, Australia
Research Site
Brussels, , Belgium
Research Site
La Louvière, , Belgium
Research Site
São Paulo, São Paulo, Brazil
Research Site
São Paulo, , Brazil
Research Site
London, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Brno, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Uherské Hradiště, , Czechia
Research Site
Dijon, , France
Research Site
Paris, , France
Research Site
Athens, , Greece
Research Site
New Territories, , Hong Kong
Research Site
Ramat Gan, , Israel
Research Site
Cinisello Balsamo (MI), , Italy
Research Site
Napoli, , Italy
Research Site
Pisa, , Italy
Research Site
Kanazawa, Ishikawa-ken, Japan
Research Site
Suita, Osaka, Japan
Research Site
Beirut, , Lebanon
Research Site
Amsterdam, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Christchurch, , New Zealand
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Observatory, Western Cape, South Africa
Research Site
Córdoba, Andalusia, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
A Coruña, Galicia, Spain
Research Site
Lugo, Galicia, Spain
Research Site
Madrid, , Spain
Research Site
Manchester, , United Kingdom
Countries
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References
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Raal FJ, Hovingh GK, Blom D, Santos RD, Harada-Shiba M, Bruckert E, Couture P, Soran H, Watts GF, Kurtz C, Honarpour N, Tang L, Kasichayanula S, Wasserman SM, Stein EA. Long-term treatment with evolocumab added to conventional drug therapy, with or without apheresis, in patients with homozygous familial hypercholesterolaemia: an interim subset analysis of the open-label TAUSSIG study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):280-290. doi: 10.1016/S2213-8587(17)30044-X. Epub 2017 Feb 16.
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Santos RD, Stein EA, Hovingh GK, Blom DJ, Soran H, Watts GF, Lopez JAG, Bray S, Kurtz CE, Hamer AW, Raal FJ. Long-Term Evolocumab in Patients With Familial Hypercholesterolemia. J Am Coll Cardiol. 2020 Feb 18;75(6):565-574. doi: 10.1016/j.jacc.2019.12.020.
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.
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013 Nov 5;128(19):2113-20. doi: 10.1161/CIRCULATIONAHA.113.004678. Epub 2013 Sep 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2011-005400-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110271
Identifier Type: -
Identifier Source: org_study_id
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