Taking people in FrancePhase 3
Carvedilol to prevent complications in people with cirrhosis and high portal pressure
Tests carvedilol against placebo in adults with cirrhosis and no symptoms yet.
Key facts
- Who runs it
- University Hospital, Tours
- Where
- Amiens Cedex 1, Angers, Aurillac, Besancon Cedex, Bobigny Cedex, Brest, Caen Cedex 9, Clichy, Créteil, Dijon, La Roche Sur Yon Cedex 9, Lille Cedex, Lyon Cedex 04, Marseille, Montpellier Cedex 5, Nantes, Paris, Paris Cedex 12, Pessac Cedex, Reims Cedex, Rennes, Strasbourg Cedex, Toulouse Cedex 9, Tours, and Villejuif Cedex, FranceSee the 25 sites
- Trial code
- Registry title
- Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 290 people, planned
- Started
- 17 Jun 2025
- Expected to end
- 17 Jul 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Experimental group: Patients will be treated with carvedilol.
- Control group: Patients will receive a placebo.
- Record updated
- 4 June 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- Male or female≥ 18 years of age
- Cirrhosis related to hepatitis C or hepatitis B virus without viral replication for at least 2 years; Or Cirrhosis related to alcohol consumption (active or abstinent) Or Cirrhosis related to metabolic syndrome or cryptogenic with BMI < 30 kg/m2
- 2 TE-LSM (Fibroscan®) performed in fasting conditions, using either the M or the XL probe >=25 kPa, within 12 months before inclusion
- Absence of medium or large varices or small varices with red signs at endoscopy within 3 months before inclusion
- Child-Pugh A5 to B8
- Affiliation to a French social security system
- Written informed consent obtained from the participant or participant's legal representative
- For child-bearing aged women, contraception using oral contraceptive, or intrauterine device or mechanical contraception
Who cannot take part
- History of overt ascites or encephalopathy <12 months before inclusion
- Treatment with either diuretics or lactulose or rifaximin <3 months before inclusion
- Previous transjugular intrahepatic portosystemic shunt (TIPSS) or liver transplantation
- Previous history or active hepatocellular carcinoma
- Concomitant use of Cimétidin
- Concomitant use of class I antiarythmic agents (except lidocaïn) (i.e.cibenzoline, disopyramide, flécaïnide, hydroquinidine méxilétine, propafenone, quinidine)
- Concomitant use of clonidine, méthyldopa, guanfacine, moxonidine, rilménidine
- Concomitant use of fingolimod
- Concomitant use of potent inhibitors (e.g. ketoconazole, HIV protease inhibitors) or inductors (e.g. rifampin, carbamazepine, phenytoin) of CYP3A4 (see appendix 7)
- Any history of portal hypertension related bleeding
- Baseline heart rate <65/min or systolic blood pressure <100 mm Hg
- Strict indication to selective or nonselective beta-blockers: history of acute myocardial infarction, congestive heart failure
- Strict contraindication to selective or nonselective beta-blockers:; decompensated congestive heart failure; grade 2 or 3 atrioventricular block; sinus node dysfunction without pacemaker; severe asthma according to WHO classification [63]; severe Chronic Obstructive Pulmonary Disease, defined stage 3 or 4 of the GOLD classification, i.e.FEV1<50% of the predicted value (https://goldcopd.org/); severe Raynaud disease, defined as repetitive episodes of biphasic colour (at least two) of pallor, cyanosis, erythema, in addition to paresthesia or numbness, occurring in both cold and normal environments [64]
- Known hypersensitivity to carvedilol
- Concomitant use of calcium antagonists: diltiazem, vérapamil and bépridil
- Glomerular filtration rate (CKD-Epi) < 30 mL/min
- Pregnancy or breastfeeding
- Non ability for participant to comply with the requirements of the study
- Life expectancy <12 months
Where in France
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceTaking people
- Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
- Centre Hospitalier Henri MondorAurillac, FranceTaking people
- CHU BesanconBesancon Cedex, FranceTaking people
- Assistance Publique Hopitaux De ParisBobigny Cedex, FranceTaking people
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranceTaking people
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
- Hopital BeaujonClichy, FranceTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
- Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Hospices Civils De LyonLyon Cedex 04, FranceTaking people
- Hôpital Saint JosephMarseille, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Hopitaux Universitaires Pitie SalpetriereParis, FranceTaking people
- Hopital Saint AntoineParis Cedex 12, FranceTaking people
- Centre Hospitalier Universitaire De BordeauxPessac Cedex, FranceTaking people
- Centre Hospitalier Universitaire ReimsReims Cedex, FranceTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranceTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
- Centre Hospitalier Régional Universitaire de ToursTours, FranceTaking people
- Hopital Paul BrousseVillejuif Cedex, FranceTaking people
About the trial
What the trial wants to find out
Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.
Read full original descriptionShow less
The usefulness of carvedilol to prevent decompensation of cirrhosis in patients with TE-LSM ≥ 25 kPa as a surrogate marker for clinically significant portal hypertension, has never been evaluated in a clinical trial.
The 2 groups in the trial
- CarvédilolTreatment being tested
Treatment: Experimental group: Patients will be treated with carvedilol.
- PlaceboPlacebo, for comparison
Treatment: Control group: Patients will receive a placebo.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial
- Plain-language title
- Carvedilol to prevent complications in people with cirrhosis and high portal pressureGenerated from the registry record. The registry title is the official one.
- Record updated
- 4 June 2025