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Defibrotide in the Human Endotoxemia Model --- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide

NCT02876601 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-19

Study results available
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Summary

Defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of veno-occlusive disease. Although it has been in clinical use for almost 30 years, the exact mechanism of action has never been fully elucidated. Thus, the effects of defibrotide will be investigated in the human endotoxemia model in order to gather further information on its actions.

Conditions

  • Healthy Volunteers
  • Endotoxemia

Interventions

DRUG

Defibrotide

6.25mg/kg bodyweight over 2h infusion

DRUG

Placebo (0.9% sodium chloride)

(0.9% sodium chloride) infusion over 2h infusion

DRUG

Lipopolysaccharide

bolus infusion of 2ng/kg bodyweight lps

DRUG

Placebo (0.9% sodium chloride bolus)

(0.9% sodium chloride) bolus infusion

Sponsors & Collaborators

  • Bernd Jilma

    lead OTHER

Principal Investigators

  • Bernd Jilma, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2018-02-12
Completion
2018-02-12

Countries

  • Austria

Study Locations

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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 NCT02876601 on ClinicalTrials.gov