Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban and Apixaban in Patients With Compensated Liver Cirrhosis
Who is this study for? Adult patients with cirrhosis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban and apixaban in patients with compensated liver cirrhosis (Child-Pugh class A and B). The enrolled participants receive a prophylactic single oral dose of either rivaroxaban (10 mg) or apixaban (2.5 mg) at around 8 a.m. on the day of the trial. Blood samples are taken 0.5 hours pre-dose and 1, 2, 3, 4, 6, 8, 12 hours post-dose. A follow-up telephone call is performed 5 days after the study intervention to collect safety data.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years or older
• Patient with previously diagnosed liver cirrhosis (Child-Pugh score grade A and B).
• Written informed consent
Locations
Other Locations
Switzerland
Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne
RECRUITING
Bern
Contact Information
Primary
Dr. med. Guido Stirnimann
guido.stirnimann@insel.ch
+41 31 632 47 13
Time Frame
Start Date: 2021-05-19
Estimated Completion Date: 2026-06
Participants
Target number of participants: 24
Treatments
Experimental: Rivaroxaban
Pharmacokinetics and pharmacodynamics of rivaroxaban
Experimental: Apixaban
Pharmacokinetics and pharmacodynamics of apixaban
Related Therapeutic Areas
Sponsors
Collaborators: Centre Hospitalier Universitaire Vaudois
Leads: Insel Gruppe AG, University Hospital Bern