At a glance
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Defibrotide in the Human Endotoxemia Model -- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide
In Brief
A Phase 4 clinical trial evaluating Defibrotide, Placebo (0.9% sodium chloride), and 2 other interventions for Healthy Volunteers and Endotoxemia. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
6.25mg/kg bodyweight over 2h infusion
(0.9% sodium chloride) infusion over 2h infusion
bolus infusion of 2ng/kg bodyweight lps
(0.9% sodium chloride) bolus infusion