Actively Recruiting
Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease.
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2024-06-04
300
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitari Vall d'Hebron Research Institute
Lead Sponsor
H
Hospital General Universitario Gregorio Marañon
Collaborating Sponsor
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Women of childbearing age must have a negative pregnancy test before starting and use effective contraception during treatment and shortly after
- Signing of informed consent
You will not qualify if you...
- 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 study participation
- cACLD due to hepatitis B virus under antiviral treatment
- cACLD due to hepatitis C virus cured with antiviral treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
J
Joan Genescá, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here