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

Vall d'Hebron University Hospital (HUVH)

Status and phase: Enrolling; Phase 3

Conditions: Portal Hypertension; Hepatocellular Carcinoma; Advanced Chronic Liver Disease

Treatments: Drug: Zinc Acexamate

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06434753

IC/LV/ACZ/PCHC

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both sexes with diagnosed compensated advanced chronic liver disease (cACLD) determined by hepatic stiffness on transient elastography >15 kPa.
• Age between 18 and 80 years, inclusive.
• Absence of prior or current decompensation.
• For women of childbearing age, a possible pregnancy will be ruled out by a pregnancy test prior to the start of the study. Following the test, the woman must use an effective contraceptive method during sexual intercourse (see Appendix I) in the days leading up to the start of treatment, and continue to use it throughout the treatment period, as well as for several days after its completion.
• Signing of informed consent.

Exclusion criteria

• History or current presence of hepatocellular carcinoma.
• Concomitant systemic disease with a short-term poor prognosis.
• Pregnancy, breastfeeding, or refusal to use contraceptive measures during participation in the study.
• Patients with compensated advanced chronic liver disease (cACLD) due to hepatitis B virus (HBV) under antiviral treatment, and those with cACLD due to hepatitis C virus (HCV) cured with antiviral treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Zinc Acexamate

Experimental group

Description:

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.

Treatment:

Drug: Zinc Acexamate

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Zinc Acexamate