RecruitingPhase 3NCT06434753

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

Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease: A Multicenter, Randomized, Double-blind, Placebo Controlled Clinical Trial

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

300 participants

Start Date

Oct 2, 2022

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Advanced Chronic Liver Disease Portal Hypertension

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether zinc supplements can slow or prevent serious liver complications (such as fluid buildup or internal bleeding) in people with advanced chronic liver scarring (fibrosis) that has not yet caused major symptoms. **You may be eligible if...** - You are between 18 and 80 years old (male or female) - You have been diagnosed with advanced chronic liver disease (cACLD), confirmed by a liver stiffness measurement greater than 15 kPa on a FibroScan or similar test - Your liver disease has not yet caused major complications (no prior decompensation like ascites, bleeding, or encephalopathy) - Women of childbearing potential must agree to use effective contraception throughout the study - You have signed the informed consent form **You may NOT be eligible if...** - You have or have had liver cancer (hepatocellular carcinoma) - You are taking other systemic treatments that might interfere with the study - You are pregnant or breastfeeding - You have conditions that affect zinc metabolism or absorption Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZinc 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).