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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624142
First Posted: June 20, 2012
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Response rate of subjects with 15% or greater reduction in low density lipoprotein-cholesterol at each scheduled visit


Enrollment: 300
Actual Study Start Date: June 1, 2012
Estimated Study Completion Date: March 12, 2020
Estimated Primary Completion Date: March 12, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624142


  Show 44 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
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
First Submitted: June 5, 2012
First Posted: June 20, 2012
Last Update Posted: June 14, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs