Zinc supplementation to improve outcomes in patients with advanced liver disease
Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease: A Multicenter, Randomized, Double-blind, Placebo Controlled Clinical Trial
This study is testing if taking zinc can help people with advanced liver disease live longer and avoid serious health problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06434753 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial aims to evaluate the effects of zinc acexamate supplementation on patients with compensated advanced chronic liver disease (cACLD). The study will enroll 300 participants who will be randomly assigned to receive either the zinc treatment or a placebo, with a follow-up period of at least two years. The primary goal is to determine if zinc can reduce the incidence of clinical events such as liver decompensation, hepatocellular carcinoma, and mortality. The trial utilizes the ANTICIPATE model to stratify patient risk and assess the potential benefits of zinc supplementation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with diagnosed compensated advanced chronic liver disease and no history of liver decompensation.
Not a fit: Patients with a history of hepatocellular carcinoma or those with other serious systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve liver function and reduce serious complications in patients with advanced chronic liver disease.
How similar studies have performed: While zinc supplementation has shown promise in related conditions, this specific approach in advanced chronic liver disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Joan Genescá, MD, PhD
- Email: joan.genesca@vallhebron.cat
- Phone: 934 89 30 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.