A Phase 2 interventional study of CER-001 in Heterozygous Familial Hypercholesterolemia, sponsored by Cerenis Therapeutics, SA. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-03.
Sponsored by Cerenis Therapeutics, SA · Phase 2, Interventional, and Treatment
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.
245 studies on the registry are indexed under Hyperlipoproteinemia Type II; 52 are open to participants now.
This study's enrollment of 10 is below the median of 86 across 170 interventional studies indexed under Hyperlipoproteinemia Type II.
Browse Hyperlipoproteinemia Type II studies →Cerenis Therapeutics, SA is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Open label single arm study of CER-001
Drug: CER-001
Weekly injection
Change in Total Plaque Volume
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)
Time frame: Baseline and 3 weeks post final dose
Percent Change in Plaque Volume
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)
Time frame: Baseline and 3 weeks post final dose
Change in carotid plaque volume
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
Time frame: Baseline and 3 weeks post final dose
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Cerenis Therapeutics, SA