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Completed

NCT Number: NCT01515241

Exploratory Study of Plaque Regression

Despite the availability of several classes of very effective drugs available to treat heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need for new, effective and well tolerated therapies. There are a number of therapies given on a chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs, but subjects with heterozygous Familial Hypercholesterolemia remain at high risk for cardiovascular events. There is still a need for acute therapies that can lead to rapid pacification of unstable plaque in order to reduce the risk of these events. This study will assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and intravascular ultrasound (IVUS) evaluations in patients with HeFH.

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Key information

Conditions

Heterozygous Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female subjects at least 18 years old
  • Subject presents heterozygous FH, known CHD and receiving maximally tolerated lipid modifying therapy, at stable doses for at least 3 months
  • LDL-C of > 110 mg/dl
  • Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS

Exclusion criteria

  • Confirmed diagnosis of homozygous FH
  • Significant health problems (other than cardiovascular disease) in the recent past including blood disorders, cancer, or digestive problems
  • Female subjects not meeting the study definition of non child-bearing potential
  • Use of an investigational agent within 30 days of the first CER-001 dose
  • Receiving current lipid apheresis

Treatment and study plan

CER-001

Drug

Weekly injection

Primary outcomes

  1. Change in Total Plaque Volume

    Time frame: Baseline and 3 weeks post final dose

    Nominal change in total plaque volume (ACTPV), as assessed by 3D IVUS, from the baseline measurement to the follow-up taken ~3 weeks following the final dose of study medication (approximately 10 weeks after the baseline assessment)

Secondary outcomes

  1. Percent Change in Plaque Volume

    Time frame: Baseline and 3 weeks post final dose

    Percent change in total plaque volume (PCTPV), as assessed by IVUS, from the baseline measurement to the follow up taken approximately 3 weeks following the final dose of study medication (approximately 10 weeks after the baseline assessment)

  2. Change in carotid plaque volume

    Time frame: Baseline and 3 weeks post final dose

    Percent change in total carotid plaque volume, as assessed by 3TMRI, from the baseline measurement to the follow up taken approximately 3 weeks following the final dose of study medication

Sponsors and collaborators

Lead sponsor

Cerenis Therapeutics, SA

Industry

Registry information

Official study title

EXPLORATORY STUDY OF PLAQUE REGRESSION:A Phase II Single Center Open-Label Exploratory Trial of the Effect of CER 001 in Subjects With Familial Hypercholesterolemia

Acronym: EXPRESS

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 24, 2012
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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