Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects

Completed · Phase 2

Conditions studied: Homozygous Familial Hypercholesterolemia

In brief

The available medications used to treat HoFH are targeted at reducing circulating levels of total and LDL-cholesterol. These measures can retard the progression of cardiovascular disease, however, they are unlikely to regress existing disease due to years of cholesterol accumulation in the vessel walls and therefore cannot adequately reduce the existing risk for an ischemic event. HDL has multiple actions that could lead to plaque stabilization and regression, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. 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 measurements in patients with HoFH.

Key facts

Study ID

NCT01412034

Run by

Cerenis Therapeutics, SA

People needed

23

Starts

2011-11-01

Expected to finish

2014-08-01

Last updated by the study team

2015-08-18

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subject 12 years or older
• Subject presents with Homozygous FH

You may not qualify if…

• Weight >100 kg
• Subjects with significant health problems in the recent past including blood disorders, cancer, or digestive problems
• Female subjects of child-bearing potential
• Known major hematologic, renal , hepatic, metabolic, gastrointestinal or endocrine dysfunction
• Contraindication to MRI scanning that would preclude the use of contrast-enhanced 3TMRI

Where it is running

• Clinical Research Facility — Hartford, Connecticut, United States
• Clinical Research Facility — North Massapequa, New York, United States
• Clinical Research Facility — Chicoutimi, Quebec, Canada
• Clinical Research Facility — Québec, Quebec, Canada
• Clinical Research Facility — Rome, Italy
• Clinical Research Facility — Amsterdam, Netherlands
• Clinical Research Facility — Maastricht, Netherlands
• Clinical Research Facility — Nijmegen, Netherlands
• Clinical Research Facility — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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