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NOT YET RECRUITING
NCT06263816
PHASE3

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

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

Summary

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. 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2025-06-17

Completion Date

2030-07-17

Last Updated

2025-06-04

Healthy Volunteers

No

Interventions

DRUG

Experimental group: Patients will be treated with carvedilol.

Patients will receive the number of pills of carvedilol corresponding to the dose determined during the titration period (either one pill of 6.25 mg in the morning or 1 pill of 6.25 mg twice a day, 1 in the morning and 1 in the evening.

OTHER

Control group: Patients will receive a placebo.

Patients will receive the number of pills of placebo corresponding to the dose determined during the titration period (either one pill in the morning or 1 pill twice a day: 1 in the morning and 1 in the evening).

Locations (24)

CHU Amiens Picardie

Amiens, France

CHU Angers

Angers, France

CHU Beaujon

Assistance Publique Hôpitaux de Paris, France

CHU Jean Minjoz

Besançon, France

CHU Haut Lévêque

Bordeaux, France

CHU Caen

Caen, France

CH intercommunal de Créteil

CH Intercommunal de Créteil, France

CHU Clermont Ferrand

Clermont-Ferrand, France

Hôpital Henri Mondor

Créteil, France

Hôpital Francois Mitterrand

Dijon, France

CHU Grenoble

Grenoble, France

Centre Hospitalier départemental de Vendée

La Roche-sur-Yon, France

Hôpital Huriez

Lille, France

CHU la Croix Rousse

Lyon, France

CHU de Montpellier

Montpellier, France

CHU Hôtel Dieu

Nantes, France

CHU Avicenne

Paris, France

CHU Pitié-Salpêtrière

Paris, France

CHU Saint-Antoin

Paris, France

CHU de Reims

Reims, France

CHU Pontchaillou

Rennes, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

CHU de Toulouse

Toulouse, France

Hôpital Paul Brousse

Villejuif, France