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

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 18, 2017

Primary Completion Date

February 12, 2018

Study Completion Date

February 12, 2018

Conditions
Healthy VolunteersEndotoxemia
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

Trial Locations (1)

1090

Department of Clinical Pharmacology, Medical University of Vienna, Vienna

All Listed Sponsors
lead

Bernd Jilma

OTHER

NCT02876601 - Defibrotide in the Human Endotoxemia Model --- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide | Biotech Hunter | Biotech Hunter