Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease.
Status:
RECRUITING
Trial end date:
2026-03-02
Target enrollment:
Participant gender:
Summary
Zinc homeostasis could play a role in advanced chronic liver disease (cACLD) and its supplementation has been linked with improvement in liver function, decrease of hepatic complications and reduction in hepatocellular carcinoma (HCC) incidence. cACLD encompasses a heterogeneous group of patients with a variable risk of clinically significant portal hypertension (CSPH) and clinical events. The ANTICIPATE model is a validated model for stratifying these risks. Our aim is to demonstrate that the administration of zinc can reduce the rate and risk of presenting clinical events (first decompensation, HCC, death and liver transplantation). This study protocol describes an ongoing phase III, national, multicentre, randomized, double-blind clinical trial that will enroll 300 patients to receive either the trial treatment (zinc acexamate) or placebo. An inclusion period of 42 months is planned, with a minimal duration of follow up of 2 years. Our principal hypothesis is that zinc could modify the natural history of cACLD patients, with an overall improvement in prognosis
Phase:
PHASE3
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborators:
Complejo Hospitalario de Toledo Germans Trias i Pujol Hospital Hospital Clinic of Barcelona Hospital de la Santa creu i Sant Pau - Barcelona Hospital del Mar Hospital General Universitario Gregorio Marañon Hospital Miguel Servet Hospital Universitari de Bellvitge Hospital Universitario Central de Asturias Hospital Universitario Marqués de Valdecilla Hospital Universitario Puerta del Hierro Hospital Vall d'Hebron Parc Taulí Hospital Universitari University Hospital of Girona Dr.Josep Trueta