Investigating Rivaroxaban and Apixaban in Patients with Liver Cirrhosis
Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban and Apixaban in Patients With Compensated Liver Cirrhosis
This study is testing how well the blood thinners rivaroxaban and apixaban work in people with liver cirrhosis to see if they can improve treatment options for them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT04874428 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the pharmacokinetic and pharmacodynamic effects of rivaroxaban and apixaban in patients with compensated liver cirrhosis, specifically those classified as Child-Pugh class A and B. Participants will receive a single oral dose of either medication, followed by blood sample collection at various intervals to assess drug absorption and effects. A follow-up call will be conducted five days post-dose to gather safety information. The study seeks to improve anticoagulation strategies for patients with liver cirrhosis, addressing limitations of current treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of compensated liver cirrhosis (Child-Pugh class A and B).
Not a fit: Patients with active bleeding, known coagulation disorders, or those requiring other anticoagulant therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective oral anticoagulation option for patients with liver cirrhosis.
How similar studies have performed: While the use of rivaroxaban and apixaban in this specific population is novel, previous studies have shown success with anticoagulation in cirrhotic patients using other methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Patient with previously diagnosed liver cirrhosis (Child-Pugh score grade A and B). * Written informed consent Exclusion Criteria: * Positive pregnancy test (only for women in childbearing age with intact uterus), pregnancy or nursing women * Intake of prophylactic or therapeutic oral anticoagulant (phenprocoumon, acenocoumarol, dabigatran etc.) 2 weeks prior to inclusion in the study * Application of parenteral anticoagulant, e.g. unfractionated heparin, low molecular weight heparins, heparin derivatives (fondaparinux etc.) 1 week prior to inclusion in the study * Pharmacologic platelet inhibition within 2 weeks prior to inclusion in the study * Known coagulation disorders (e.g. von Willebrand's disease, hemophilia) * Active, clinically significant bleeding * Congenital or acquired bleeding disorder * High risk of bleeding (e.g. active ulcerative gastrointestinal disease) * Uncontrolled severe hypertension * Vascular retinopathy * Acute infection * Acute bacterial endocarditis * Severe anemia (haemoglobin ≤100 g/L) * Hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption * Severe liver dysfunction (Child-Pugh Score grade C) * Hepatic encephalopathy ≥ grade 3 * Severe renal impairment with a creatinine clearance (GFR) of \<30 ml/min * Known intolerance to the study medications rivaroxaban and/or apixaban * Concomitant treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, lopinavir, ritonavir, indinavir). * Concomitant treatment with a P-glycoprotein inhibitor and a weak or moderate CYP3A4 inhibitor (e.g., erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine). * Concomitant treatment with a P-glycoprotein inducer and a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampicin). * Wash-out period of less than two weeks prior to the application of study drug in case of prior treatment with a strong CYP3A4 inhibitor or a P-glycoprotein inhibitor and weak or moderate CYP3A4 inhibitor or with a P-glycoprotein inducer or strong CYP3A4 inducer.
Where this trial is running
Bern
- Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Dr. med. Guido Stirnimann — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Dr. med. Guido Stirnimann
- Email: guido.stirnimann@insel.ch
- Phone: +41 31 632 47 13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.