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Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities (TESLA)

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ClinicalTrials.gov Identifier: NCT01588496
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : October 2, 2015
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Condition or disease Intervention/treatment Phase
Homozygous Familial Hypercholesterolemia Biological: Evolocumab Drug: Placebo Phase 2 Phase 3

Detailed Description:

Study Masking:

Part A: Open Label Part B: Double Blind

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia
Actual Study Start Date : April 5, 2012
Actual Primary Completion Date : January 31, 2014
Actual Study Completion Date : January 31, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: Evolocumab
Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Experimental: Part B: Evolocumab
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Placebo Comparator: Part B: Placebo
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
 Drug: Placebo
Administered by subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was quantified using the ultracentrifugation method.

  2. Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was quantified using the ultracentrifugation method.


Secondary Outcome Measures :
  1. Part A: Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was quantified using the ultracentrifugation method.

  2. Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
  3. Part A: Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
  4. Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
  5. Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
  6. Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was quantified using the ultracentrifugation method.

  7. Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12 [ Time Frame: Baseline and Week 12 ]
  8. Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12 [ Time Frame: Baseline and Weeks 6 and 12 ]
    LDL-C was quantified using the ultracentrifugation method.

  9. Part B: Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
  10. Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12 [ Time Frame: Baseline and Weeks 6 and 12 ]
  11. Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline and Week 12 ]
  12. Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12 [ Time Frame: Baseline and Weeks 6 and 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females ≥ 12 to ≤ 80 years of age
  • Diagnosis of homozygous familial hypercholesterolemia
  • Stable lipid-lowering therapies for at least 4 weeks
  • LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
  • Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
  • Bodyweight of ≥ 40 kg at screening.

Exclusion Criteria:

  • LDL or plasma apheresis within 8 weeks prior to randomization
  • New York Heart 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 randomization
  • Planned cardiac surgery or revascularization
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
Contacts and Locations
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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): NCT01588496


Locations
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United States, New York
Research Site
New York, New York, United States, 10032
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45227
Belgium
Research Site
Bruxelles, Belgium, 1200
Research Site
La Louvière, Belgium, 7100
Canada, Ontario
Research Site
London, Ontario, Canada, N6A 5K8
Canada, Quebec
Research Site
Chicoutimi, Quebec, Canada, G7H 7K9
Czechia
Research Site
Brno, Czechia, 656 91
Research Site
Hradec Kralove, Czechia, 500 05
Research Site
Uherske Hradiste, Czechia, 686 01
France
Research Site
Dijon, France, 21000
Research Site
Paris Cedex 13, France, 75651
Hong Kong
Research Site
New Territories, Hong Kong
Italy
Research Site
Pisa, Italy, 56124
Lebanon
Research Site
Beirut, Lebanon, 0000
Netherlands
Research Site
Amsterdam, Netherlands, 1105 AZ
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
Lugo, Galicia, Spain, 27003
Research Site
Madrid, Spain, 28040
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01588496    
Other Study ID Numbers: 20110233
2011-005399-40 ( EudraCT Number )
First Posted: May 1, 2012    Key Record Dates
Results First Posted: October 2, 2015
Last Update Posted: November 29, 2018
Last Verified: November 2018
Keywords provided by Amgen:
hypercholesterolemia
familial hypercholesterolemia
homozygous familial hypercholesterolemia
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
 Genetic Diseases, Inborn
Hyperlipoproteinemias
Evolocumab
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents