Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders (TAUSSIG)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01624142
First received: June 5, 2012
Last updated: March 31, 2015
Last verified: March 2015
  Purpose

A study to assess the long term safety and efficacy of Evolocumab (AMG145)on Low Density Lipoprotein-Cholesterol (LDL-C) in subjects with severe familial hypercholesterolemia.


Condition Intervention Phase
Severe Familial Hypercholesterolemia
Biological: Evolocumab (AMG145)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of treatment emergent adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Subject incidence of treatment emergent adverse events


Secondary Outcome Measures:
  • Percent change in low density lipoprotein-cholesterol [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]
    Percent change in low density lipoprotein-cholesterol from baseline open label at each scheduled visit

  • Percent change in non-high density lipoprotein-cholesterol [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]
    Percent change in non-high density lipoprotein- cholesterol from baseline open label at each scheduled visit

  • Percent change in apolipoprotein B [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]
    Percent change in apolipoprotein B from baseline open label at each scheduled visit

  • Percent change in total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]
    Percent change in total cholesterol/high density lipoprotein-cholesterol ratio from baseline open label at each scheduled visit

  • Percent change in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]
    Percent change in apolipoprotein B/apolipoprotein A1 ratio from baseline open label at each scheduled visit

  • Percent change in lipoprotein(a) [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]
    Percent change in lipoprotein(a) from baseline open label at each scheduled visit

  • Response rate of subjects with 15% or greater reduction in low density lipoprotein-cholesterol [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]
    Response rate of subjects with 15% or greater reduction in low density lipoprotein-cholesterol at each scheduled visit


Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 of subcutaneous Evolocumab (AMG145)
Dose 1 of subcutaneous Evolocumab (AMG145)every month
Biological: Evolocumab (AMG145)
every month
Experimental: Dose 2 of subcutaneous Evolocumab (AMG145)
Dose 2 of subcutaneous Evolocumab (AMG145)every 2 weeks
Biological: Evolocumab (AMG145)
every 2 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participated in a qualifying Evolocumab (AMG145) parent protocol 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 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)
  • Bodyweight of > 40 kg or greater at screening for subjects less than 18 years of age

Exclusion Criteria:

  • New York Heart Failure Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624142

  Hide Study Locations
Locations
United States, California
Research Site
Los Angeles, California, United States, 90048
United States, New York
Research Site
New York, New York, United States, 10021
Research Site
New York, New York, United States, 10032
Research Site
New York, New York, United States, 10029
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45227
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37232
Australia, Tasmania
Research Site
Hobart, Tasmania, Australia, 7000
Australia, Western Australia
Research Site
Perth, Western Australia, Australia, 6000
Belgium
Research Site
Bruxelles, Belgium, 1200
Research Site
La Louvière, Belgium, 7100
Brazil
Research Site
Sao Paulo, São Paulo, Brazil, 04039-030
Research Site
São Paulo, Brazil, 05403-000
Canada, Ontario
Research Site
London, Ontario, Canada, N6A 5K8
Canada, Quebec
Research Site
Chicoutimi, Quebec, Canada, G7H 7K9
Research Site
Montreal, Quebec, Canada, H3A 1A1
Research Site
Montreal, Quebec, Canada, H2W 1R7
Canada
Research Site
Quebec, Canada, G1V 4M6
Czech Republic
Research Site
Brno, Czech Republic, 656 91
Research Site
Hradec Kralove, Czech Republic, 500 05
Research Site
Olomouc, Czech Republic, 775 20
Research Site
Praha 2, Czech Republic, 128 08
Research Site
Uherske Hradiste, Czech Republic, 686 01
France
Research Site
Dijon, France, 21000
Research Site
Paris Cedex 13, France, 75651
Greece
Research Site
Athens, Greece, 17674
Hong Kong
Research Site
New Territories, Hong Kong
Israel
Research Site
Ramat Gan, Israel, 52621
Italy
Research Site
Cinisello Balsamo (MI), Italy, 20092
Research Site
Napoli, Italy, 80131
Research Site
Pisa, Italy, 56124
Japan
Research Site
Kanazawa, Ishikawa, Japan, 920-8641
Research Site
Suita, Osaka, Japan, 565-8565
Lebanon
Research Site
Beirut, Lebanon, 0000
Netherlands
Research Site
Amsterdam, Netherlands, 1105 AZ
Research Site
Rotterdam, Netherlands, 3045 PM
New Zealand
Research Site
Christchurch, New Zealand, 8011
South Africa
Research Site
Johannesburg, Gauteng, South Africa, 2193
Research Site
Observatory, Western Cape, South Africa, 7925
Spain
Research Site
Cordoba, Andalucía, Spain, 14004
Research Site
Barcelona, Cataluña, Spain, 08036
Research Site
A Coruña, Galicia, Spain, 15001
Research Site
Lugo, Galicia, Spain, 27003
Research Site
Madrid, Spain, 28040
United Kingdom
Research Site
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01624142     History of Changes
Other Study ID Numbers: 20110271
Study First Received: June 5, 2012
Last Updated: March 31, 2015
Health Authority: Czech Republic: State Institute for Drug Control (SUKL)
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO
South Africa: MCC
Brazil: ANVISA (Agencia Nacional de Vigilancia Sanitária)
Hong Kong: Department of Health
New Zealand: MEDSAFE (New Zealand Medicines and Medical Devices Safety Authority)
Canada: Canadian Agency is Health Canada _ Biologics and Genetic Therapies Directorate.
United States: Food and Drug Administration
Lebanon: Institutional Review Board
Japan: Pharmaceuticals and Medical Devices Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Greece: National Organization of Medicines
Israel: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Amgen:
Hypercholesterolemia
Elevated Cholesterol
High Cholesterol
Homozygous Familial Hypercholesterolemia
PCSK9 mutations
Severe Familial Hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Dyslipidemias
Genetic Diseases, Inborn
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on May 04, 2015