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

This study is currently recruiting participants.
Verified February 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01624142
First received: June 5, 2012
Last updated: February 25, 2014
Last verified: February 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
Drug: 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: 250
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
Drug: Evolocumab (AMG145)
every month
Experimental: Dose 2 of subcutaneous Evolocumab (AMG145)
Dose 2 of subcutaneous Evolocumab (AMG145)every 2 weeks
Drug: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624142

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 35 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: February 25, 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
Turkey: Ministry of Health, the Republic of Turkey
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
Austria: Agency for Health and Food Safety

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
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on April 17, 2014