MedTrace Logo

Treatment of Severe Infection With Antihyperlipidemia Drug

NCT03634293 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 712

Last updated 2018-08-16

No results posted yet for this study

Summary

Proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors increase LDL receptors by decreasing its degradation. In sepsis the pathogenic substances, endotoxin, lipoteichoic acid, phospholipomannan are the main cause of the ongoing inflammation that causes the severe damage and outcome. these substances are removed from the blood by the LDL receptors. By administering PCSK9 inhibitors to patients with sepsis/septic shock this inflammatory response can be stopped and by doing so improve the patients outcome.

Conditions

Interventions

DRUG

Alirocumab Injectable Product

Alirocumab is an human monoclonal antibodies directed against Proprotein convertase subtilisin/kexin type 9 (PCSK9). It is administered once every two weeks subcutaneously.

DRUG

Saline Solution

The placebo will be 2 ml' of 0.9% saline injected subcutaneously.

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    collaborator OTHER_GOV

  • Sanofi

    collaborator INDUSTRY

  • Wolfson Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ziv Rosman, MD · Wolfson Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2021-01-31
Completion
2021-02-28

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03634293 on ClinicalTrials.gov