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Liver cirrhosis patients get tested on common blood thinners

NCT ID NCT04874428

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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

    RECRUITING

    Bern, 3010, Switzerland

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