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

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether zinc supplementation can improve health outcomes for patients with compensated advanced chronic liver disease (cACLD). Researchers believe that zinc might help enhance liver function and lower the risks of serious complications such as liver failure, liver cancer, and the need for a liver transplant. The study will involve 300 patients who will be randomly assigned to receive either zinc acexamate (the trial treatment) or a placebo (a treatment with no active ingredients). The trial is designed to last for about 42 months, and participants will be monitored for at least two years.

To be eligible for this study, participants must be between 18 and 80 years old, have a diagnosis of cACLD confirmed through a specific test, and must not have experienced any liver-related complications. Women who can become pregnant will need to have a negative pregnancy test and agree to use effective birth control during the study. Participants can expect regular check-ups and support throughout the trial, helping to ensure their safety and well-being. This research is important because it could lead to new ways to help manage and improve the future health of people living with this challenging condition.

Gender

ALL

Eligibility criteria

• 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.