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RECRUITING
NCT04874428
PHASE1

Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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.

Official title: Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban and Apixaban in Patients With Compensated Liver Cirrhosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2021-05-19

Completion Date

2026-06

Last Updated

2026-02-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Rivaroxaban 10 mg Oral Tablet

Administration of one single dose of rivaroxaban (10 mg) in tablet form.

DRUG

Apixaban 2.5 mg Oral Tablet

Administration of one single dose of apixaban (2.5 mg) in tablet form.

Locations (1)

Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne

Bern, Switzerland