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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02697136
Other study ID # CER-001-CLIN-009
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 2015
Est. completion date December 21, 2018

Study information

Verified date February 2019
Source Cerenis Therapeutics, SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Subjects will be required to have acceptable baseline 3TMRI imaging of carotid arteries. Subjects meeting all eligibility criteria will be randomized to receive CER-001 or placebo (2:1 randomization scheme). Randomized subjects will return weekly for a total of 9 infusions and then biweekly for an additional 20 infusions. 3TMRI imaging of the carotid and femoral arteries will be performed at Week 8, Week 24 (primary endpoint) and Week 48. The total study duration from randomization can range from 50 to 54 weeks for patients completing the study as designed.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CER-001
Recombinant human apoA-I/phospholipid complexes
Placebo
0.9% Sodium Chloride Injection, USP

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Cerenis Therapeutics, SA

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Israel,  Italy,  Netherlands, 

Outcome

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