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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01624142
First received: June 5, 2012
Last updated: October 10, 2014
Last verified: October 2014
  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


Estimated Enrollment: 310
Study Start Date: June 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: November 2019 (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

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 43 Study Locations
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: October 10, 2014
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 November 20, 2014