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 July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01624142
First received: June 5, 2012
Last updated: July 16, 2014
Last verified: July 2014

June 5, 2012
July 16, 2014
June 2012
November 2019   (final data collection date for primary outcome measure)
Subject incidence of treatment emergent adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Subject incidence of treatment emergent adverse events
Same as current
Complete list of historical versions of study NCT01624142 on ClinicalTrials.gov Archive Site
  • 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
  • Percent change in Low Density Lipoprotein - Cholesterol (LDL-C) from Day 1 Open Label (OL) [ Time Frame: Every 3 months over 5 years ] [ Designated as safety issue: No ]
    Percent change in Low Density Lipoprotein - Cholesterol (LDL-C) from Day 1 Open Label (OL) at each 3 month visit
  • Percent change in non-High Density Lipoprotein - Cholesterol (non-HDL-C) from Day 1 Open Label (OL) [ Time Frame: Every 3 months over 5 years ] [ Designated as safety issue: No ]
    Percent change in non-High Density Lipoprotein - Cholesterol (non-HDL-C) from Day 1 Open Label (OL) at each 3 month visit
  • Percent change in Apolipoprotein B (ApoB) from Day 1 Open Label (OL) [ Time Frame: Every 3 months over 5 years ] [ Designated as safety issue: No ]
    Percent change in Apolipoprotein B (ApoB) from Day 1 Open Label (OL) at each 3 month visit
  • Percent change in total cholesterol/High Density Lipoprotein - Cholesterol (HDL-C) ratio from Day 1 Open Label (OL) [ Time Frame: Every 3 months over 5 years ] [ Designated as safety issue: No ]
    Percent change in total cholesterol/High Density Lipoprotein - Cholesterol (HDL-C) ratio from Day 1 Open Label (OL) at each 3 month visit
  • Percent change in Apolipoprotein B (ApoB)/Apolipoprotein A1 (ApoA1) ratio from Day 1 Open Label (OL) [ Time Frame: Every 3 months over 5 years ] [ Designated as safety issue: No ]
    Percent change in Apolipoprotein B (ApoB)/Apolipoprotein A1 (ApoA1) ratio from Day 1 Open Label (OL) at each 3 month visit
Not Provided
Not Provided
 
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Familial Hypercholesterolemia
  • Biological: Evolocumab (AMG145)
    every month
  • Biological: Evolocumab (AMG145)
    every 2 weeks
  • Experimental: Dose 1 of subcutaneous Evolocumab (AMG145)
    Dose 1 of subcutaneous Evolocumab (AMG145)every month
    Intervention: Biological: Evolocumab (AMG145)
  • Experimental: Dose 2 of subcutaneous Evolocumab (AMG145)
    Dose 2 of subcutaneous Evolocumab (AMG145)every 2 weeks
    Intervention: Biological: Evolocumab (AMG145)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
310
January 2020
November 2019   (final data collection date for primary outcome measure)

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
Both
12 Years to 80 Years
No
Contact: Amgen Call Center 866-572-6436
United States,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Greece,   Hong Kong,   Israel,   Italy,   Japan,   Lebanon,   Netherlands,   New Zealand,   South Africa,   Spain,   United Kingdom
 
NCT01624142
20110271
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP