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

• Status: Completed
• Trial end date: 2018-02-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bernd Jilma
• Treatments: Defibrotide

Criteria

Inclusion Criteria:

• >18 years of age

• <90kg body weight

• Normal findings in medical history and physical examination unless the investigator considers the abnormality to be clinically irrelevant

• Normal laboratory values unless the investigator considers abnormalities to be clinically irrelevant

• Ability to understand the purpose and nature of the study, as well as the associated risks

Exclusion Criteria:

• Intake of any drugs that may interfere with the trial's endpoints or drugs (i.e. platelet inhibitors, anticoagulants, etc.)

• Positive results of HIV or hepatitis virology

• Acute illness with systemic inflammatory reactions

• Known allergies, hypersensitivities or intolerances to any of the used substances

• Acute or recent bleeding episodes, increased risk of bleeding at the discretion of the investigator

• Participation in an LPS trial within 6 weeks of the first study day

• Pregnancy or breastfeeding