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Exploratory Study of Plaque Regression (EXPRESS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cerenis Therapeutics, SA
ClinicalTrials.gov Identifier:
NCT01515241
First received: January 18, 2012
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Heterozygous Familial Hypercholesterolemia
 Drug: CER-001
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Cerenis Therapeutics, SA:

Primary Outcome Measures:
  • Change in Total Plaque Volume [ Time Frame: Baseline and 3 weeks post final dose ] [ Designated as safety issue: No ]
    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:
  • Percent Change in Plaque Volume [ Time Frame: Baseline and 3 weeks post final dose ] [ Designated as safety issue: No ]
    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)

  • Change in carotid plaque volume [ Time Frame: Baseline and 3 weeks post final dose ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open label single arm study of CER-001
Open label single arm study of CER-001
 Drug: CER-001
Weekly injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Cerenis Therapeutics, SA
ClinicalTrials.gov Identifier: NCT01515241     History of Changes
Other Study ID Numbers: CER-001-CLIN-005
Study First Received: January 18, 2012
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 19, 2013