Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

NCT03320265 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-07-06

No results posted yet for this study

Summary

Inflammation and abnormal amount of lipids in the blood are key factors for the development and progression of atherosclerosis (thickening of the artery wall) and cardiovascular disease. Lipoprotein (a) is a pro-inflammatory plasma lipoprotein that is believed to be a risk factor for cardiovascular diseases. Vascular inflammation generates a range of effects, including endothelial dysfunction and migration of white blood cells into the vessel wall, which results in increased risk of cardiovascular events.

This study is designed to assess the effects of multiple monthly intravenous infusions with the fully human antibody called PC-mAb, in subjects with elevated lipoprotein (a).

Conditions

Interventions

DRUG

PC-mAb

Monthly treatment for 3 months (4 administrations)

DRUG

Placebo

Monthly treatment for 3 months (4 administrations)

Sponsors & Collaborators

  • Athera Biotechnologies AB

    lead INDUSTRY

Principal Investigators

  • Eric SG Stroes, MD, Prof. · Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2018-03-19
Completion
2018-07-03

Countries

  • Netherlands
  • Sweden

Study Locations

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Entities

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 NCT03320265 on ClinicalTrials.gov