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Trial record 3 of 4 for:    17387133 [PUBMED-IDS]

Exploratory Study of Plaque Regression (EXPRESS)

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ClinicalTrials.gov Identifier: NCT01515241
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
Cerenis Therapeutics, SA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heterozygous Familial Hypercholesterolemia Drug: CER-001 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Open label single arm study of CER-001
Open label single arm study of CER-001
Drug: CER-001
Weekly injection




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01515241


Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T1C8
Sponsors and Collaborators
Cerenis Therapeutics, SA
Investigators
Principal Investigator: Jean-Claude Tardif, MD Montreal Heart Institute

Publications:

Responsible Party: Cerenis Therapeutics, SA
ClinicalTrials.gov Identifier: NCT01515241     History of Changes
Other Study ID Numbers: CER-001-CLIN-005
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: January 2014

Keywords provided by Cerenis Therapeutics, SA:
Heterozygous Familial Hypercholesterolemia
Familial Hypercholesterolemia
HDL mimetic
ApoA-1

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