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CER-001 Therapy as a Novel Approach to Treat Genetic Orphan Diseases

NCT02697136 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-22

Study results available
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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.

Conditions

  • Familial Hypoalphalipoproteinemia

Interventions

DRUG

CER-001

Recombinant human apoA-I/phospholipid complexes

DRUG

Placebo

0.9% Sodium Chloride Injection, USP

Sponsors & Collaborators

  • Cerenis Therapeutics, SA

    lead INDUSTRY

Principal Investigators

  • Erik SG Stroes, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-10-31
Completion
2018-12-21

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02697136 on ClinicalTrials.gov