BridgeMD
New treatment option for Liver Cirrhosis
Official title Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis
ClinicalTrials.gov ID: NCT04874428
What this study is testing
What is Rivaroxaban 10 mg Oral Tablet?
Rivaroxaban 10 mg Oral Tablet is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for liver cirrhosis.
Also referred to as Xarelto.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Patient with previously diagnosed liver cirrhosis (Child-Pugh score grade A and B).
- Written informed consent
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Age 18 years or older
- Patient with previously diagnosed liver cirrhosis (Child-Pugh score grade A and B).
- Written informed consent
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.