drugset / Trial / 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
Phase 3
Not yet recruiting
290 enrolled
University Hospital, Tours
Assistance Publique Hopitaux Paris AVICENNE · collabAssistance Publique Hopitaux Paris BEAUJON · collabAssistance Publique Hopitaux Paris HENRI MONDOR · collabAssistance Publique Hopitaux Paris PAUL BROUSSE · collabAssistance Publique Hopitaux Paris ST ANTOINE · collabCHU de Reims · collabCentre Hospitalier Régional Universitaire Lille · collabCentre Hospitalier Universitaire Amiens Picardie · collabCentre Hospitalier Universitaire Clermont Ferrand · collabCentre Hospitalier Universitaire Dijon · collabCentre Hospitalier Universitaire Grenoble · collabCentre Hospitalier Universitaire Haut Lévêque · collabCentre Hospitalier Universitaire Jean Minjoz · collabCentre Hospitalier Universitaire Pontchaillou · collabCentre Hospitalier Universitaire de Caen · collabCentre Hospitalier intercommunal de Créteil · collabCentre Hospitaliser Départemental de Vendée · collabGroupe Hospitalier Pitie-Salpetriere · collabHospices Civils de Lyon · collabHôpitaux Universitaires de Strasbourg · collabNantes University Hospital · collabUniversity Hospital, Angers · collabUniversity Hospital, Montpellier · collabUniversity Hospital, Toulouse · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2025-06-17
- Primary completion
- 2027-07-17
- Completion
- 2030-07-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carvedilol | Other / unclassified | 6.25 mg | — |