NCT02876601

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bernd Jilma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Defibrotide (DF) is a highly complex polydisperse mixture of single-stranded phosphodiester oligodeoxyribonucleotides derived from the controlled depolymerization of porcine intestinal mucosal DNA. The entire mode of action remains unknown. Its actions may be summarized to pro-fibrinolytic, anti-inflammatory and anti-coagulatory actions. To better define the mechanisms of Defibrotide the effects of the substance will be investigated in the well-established endotoxemia model. Sixteen healthy volunteers will be randomized to receive LPS±defibrotide/placebo and four subjects will be randomized to receive Placebo± defibrotide/placebo in a single center, randomized, double blind, placebo controlled, two-way crossover trial. Immediately after a 2h infusion of 6,25mg/kg bodyweight defibrotide or placebo a LPS bolus of 2ng/kg bodyweight will be infused. Analyses will be performed by blood sampling at pre-defined time-points.

Conditions

• Healthy Volunteers
• Endotoxemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-18
• Primary completion: 2018-02-12
• Completion: 2018-02-12
• First posted: 2016-08-24
• Last updated: 2019-12-19
• Results posted: 2019-12-19

Locations

1 site across 1 country: Austria