Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease.

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

Conditions

• Advanced Chronic Liver Disease
• Portal Hypertension
• Hepatocellular Carcinoma

Interventions

DRUG

Zinc Acexamate

The experimental group will receive ACZ at a daily dose of 600 mg, equivalent to 100mg of elemental zinc (one hard gelatin capsule of 300 mg of ACZ twice a day). Treatment will be stopped when the patient presents any of the events that define the main endpoint of the study. The control group will receive twice a day orally hard gelatin capsules, identical to those of ACZ, in color, weight and nature, but containing an inert preparation (isomaltose).

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Hospital Universitario Puerta del Hierro

  collaborator UNKNOWN

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital Universitario Central de Asturias

  collaborator OTHER

• Complejo Hospitalario de Toledo

  collaborator OTHER

• Germans Trias i Pujol Hospital

  collaborator OTHER

• Hospital Universitario Marqués de Valdecilla

  collaborator OTHER

• Hospital Miguel Servet

  collaborator OTHER

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Hospital de la Santa creu i Sant Pau - Barcelona

  collaborator OTHER

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• University Hospital of Girona Dr. Josep Trueta

  collaborator NETWORK

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-02

Primary Completion

2026-03-02

Completion

2026-03-02

Countries

• Spain

Study Locations