Liver cirrhosis patients get tested on common blood thinners
NCT ID NCT04874428
First seen Jun 24, 2026 · Last updated Aug 20, 2026 · Updated 4 times
Summary
This early-stage study looks at how two common blood thinners, rivaroxaban and apixaban, behave in people with compensated liver cirrhosis. 24 participants receive a single dose of one drug, and researchers measure drug levels and blood clotting markers over 12 hours. The goal is to gather safety and dosing information, not to treat the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rivaroxaban and apixaban (blood thinners)
- What this could lead to
- If successful, this could help doctors understand how to safely use these blood thinners in people with liver cirrhosis, potentially reducing clot risks.
- What could go wrong
- This is a very early, small phase 1 study with only 24 participants and single doses, so results may not apply to long-term use or broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne
RECRUITINGBern, 3010, Switzerland
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Other studies related to the condition(s) this trial covers.
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- Blood test may forecast which cirrhosis patients survive after discharge
- Can a parasite drug help fight a deadly gut infection in cirrhosis?