Familial Hypoalphalipoproteinemia Clinical Trial
— TANGOOfficial title:
Phase 3, Multicenter, Randomized, 48 Week, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate Efficacy and Safety of CER-001 on Vessel Wall Area in Patients With Genetically Defined Familial Primary Hypoalphalipoproteinemia
Verified date | February 2019 |
Source | Cerenis Therapeutics, SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs. placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid vessel wall area as measured by 3TMRI, when administered to patients with familial primary hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.
Status | Terminated |
Enrollment | 30 |
Est. completion date | December 21, 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Main Inclusion Criteria: - Male and female patients, aged 18 and above. - ApoA-I < 70 mg/dL - Symptomatic or asymptomatic cardiovascular disease - Diagnosis of genetically confirmed HDL-c deficiency due to defects in genes coding for ABCA1 and/or ApoA-1 - Stable doses of lipid lowering therapies for at least 6 weeks prior to baseline procedures Main Exclusion Criteria: - Females of childbearing potential - Patients with LCAT mutations - Patients who experienced recent cardiovascular or cerebrovascular events - Hypertriglyceridemia (>500 mg/dL) - Severe anemia (Hgb < 10 g/dL) - Uncontrolled diabetes (HbA1c >10%) - Congestive heart failure (NYHA class II or higher) - Contraindication for MRI scanning (e.g., implanted metal objects, claustrophobia) |
Country | Name | City | State |
---|---|---|---|
Belgium | Investigative Site | La Louvière | |
Canada | Investigative Site | Chicoutimi | Quebec |
Canada | Investigative Site | Halifax | Nova Scotia |
Canada | Investigative Site | London | Ontario |
Canada | Investigative Site | Montreal | Quebec |
Canada | Investigative Site | Vancouver | British Columbia |
France | Investigative Site | Lille | |
France | Investigative Site | Montpellier | |
France | Investigative Site | Rouen | |
France | Investigative Site | Toulouse | |
Israel | Investigative Site | Jerusalem | |
Israel | Investigative Site | Tel Aviv | |
Italy | Investigative Site | Genoa | |
Italy | Investigative Site | Milan | |
Italy | Investigative Site | Pisa | |
Italy | Investigative Site | Rome | |
Netherlands | Investigative Site | Amsterdam | |
Netherlands | Investigative Site | Utrecht | |
United States | Investigative Site | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Cerenis Therapeutics, SA |
United States, Belgium, Canada, France, Israel, Italy, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in femoral MVWA | Assessed by 3TMRI; change from baseline; CER-001 versus placebo | Baseline, Weeks 8, 24 and 48 | |
Primary | Change in mmean vessel wall area (MVWA) of the carotid artery | Change from baseline to Week 24 carotid MVWA; CER-001 versus placebo; measured by 3TMRI | Baseline to Week 24 | |
Secondary | Change in mean vessel wall area (MVWA) of the carotid artery | Change from baseline to Week 8 carotid MVWA; CER-001 versus placebo; measured by 3TMRI | Baseline to Week 8 | |
Secondary | Change in mean vessel wall area (MVWA) of the carotid artery | Change from baseline to Week 48 carotid MVWA; CER-001 versus placebo; measured by 3TMRI | Baseline to Week 48 | |
Secondary | Change in Target to Background Ratio (TBR) of the carotid artery | Change from baseline to Week 24 in carotid TBR; CER-001 versus placebo; measured by FDG-PET | Baseline to Week 24 |