Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | August 2014 |
Modifying Orphan Disease Evaluation (MODE) Study: A Multicenter, Open-label Study of the Effects of CER-001 on Plaque Volume in Subjects With Homozygous Familial Hypercholesterolemia (HoFH)
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.
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.
Inclusion Criteria:
- Male or female subject 12 years or older
- Subject presents with Homozygous FH
Exclusion Criteria:
- 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
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