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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

June 17, 2025

Primary Completion Date

July 17, 2027

Study Completion Date

July 17, 2030

Conditions
Asymptomatic CirrhosisClinically Significant Portal Hypertension
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).

Trial Locations (24)

Unknown

CHU Amiens Picardie, Amiens

CHU Angers, Angers

CHU Beaujon, Assistance Publique Hôpitaux de Paris

CHU Jean Minjoz, Besançon

CHU Haut Lévêque, Bordeaux

CHU Caen, Caen

CH intercommunal de Créteil, CH Intercommunal de Créteil

CHU Clermont Ferrand, Clermont-Ferrand

Hôpital Henri Mondor, Créteil

Hôpital Francois Mitterrand, Dijon

CHU Grenoble, Grenoble

Centre Hospitalier départemental de Vendée, La Roche-sur-Yon

Hôpital Huriez, Lille

CHU la Croix Rousse, Lyon

CHU de Montpellier, Montpellier

CHU Hôtel Dieu, Nantes

CHU Avicenne, Paris

CHU Pitié-Salpêtrière, Paris

CHU Saint-Antoin, Paris

CHU de Reims, Reims

CHU Pontchaillou, Rennes

Hôpitaux Universitaires de Strasbourg, Strasbourg

CHU de Toulouse, Toulouse

Hôpital Paul Brousse, Villejuif

All Listed Sponsors
collaborator

Centre Hospitalier Universitaire Amiens Picardie

UNKNOWN

collaborator

Centre Hospitalier Universitaire Angers

UNKNOWN

collaborator

Assistance Publique Hopitaux Paris BEAUJON

UNKNOWN

collaborator

Centre Hospitalier Universitaire Caen

UNKNOWN

collaborator

Centre Hospitalier intercommunal de Créteil

UNKNOWN

collaborator

Hospices Civils de Lyon

OTHER

collaborator

Centre Hospitalier Universitaire Grenoble

UNKNOWN

collaborator

Centre Hospitalier Universitaire Haut Lévêque

UNKNOWN

collaborator

Centre Hospitalier Régional Universitaire Lille

UNKNOWN

collaborator

Centre Hospitalier Universitaire Jean Minjoz

UNKNOWN

collaborator

Assistance Publique Hopitaux Paris AVICENNE

UNKNOWN

collaborator

Centre Hospitalier Universitaire Clermont Ferrand

UNKNOWN

collaborator

Assistance Publique Hopitaux Paris LA PITIE SALPETRIERE

UNKNOWN

collaborator

Centre Hospitalier Universitaire Pontchaillou

UNKNOWN

collaborator

Assistance Publique Hopitaux Paris ST ANTOINE

UNKNOWN

collaborator

Assistance Publique Hopitaux Paris PAUL BROUSSE

UNKNOWN

collaborator

University Hospital, Montpellier

OTHER

collaborator

Assistance Publique Hopitaux Paris HENRI MONDOR

UNKNOWN

collaborator

Centre Hospitaliser Départemental de Vendée

UNKNOWN

collaborator

Nantes University Hospital

OTHER

collaborator

Centre Hospitalier Universitaire Dijon

OTHER

collaborator

CHU de Reims

OTHER

collaborator

Hôpitaux Universitaires de Strasbourg

UNKNOWN

collaborator

University Hospital, Toulouse

OTHER

lead

University Hospital, Tours

OTHER

NCT06263816 - 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 | Biotech Hunter | Biotech Hunter