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Study on Zinc Acexamate for Patients with Advanced Chronic Liver Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for chronic liver disease, a condition where the liver is damaged over a long period, leading to serious health issues. The treatment being tested is called Zinc Acexamate, which is taken in the form of capsules. The purpose of the study is to see if taking Zinc Acexamate can improve the health outcomes of patients with advanced stages of chronic liver disease.

Participants in the study will be randomly assigned to receive either Zinc Acexamate or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The treatment will be taken orally, and the study will monitor the participants over a period to observe any changes in their condition.

The main goal is to determine if Zinc Acexamate can reduce the risk of serious liver-related events, such as liver failure, liver cancer, or the need for a liver transplant. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for people with chronic liver disease in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

    If you are a woman of childbearing age, a pregnancy test will be conducted to ensure you are not pregnant before starting the study. You will need to use an effective contraceptive method during the study and for a short period after it ends.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have advanced chronic liver disease, diagnosed by a specific test measuring liver stiffness.

    Your age should be between 18 and 80 years, and you should not have any previous or current liver complications.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either the study medication, zinc acexamate, or a placebo. A placebo is a substance with no active medication, used for comparison.

    The medication will be taken orally in the form of a hard capsule, named COPINAL 300 mg. You will take a total dose of 600 mg per day, which is equivalent to 100 mg of elemental zinc.

  4. Step 4

    Ongoing monitoring

    Throughout the study, your health will be closely monitored. This includes regular check-ups to track any changes in your condition and to ensure your safety.

    The study aims to evaluate if the medication improves your health by reducing the risk of liver-related complications.

  5. Step 5

    Study completion

    The study is expected to continue until January 25, 2028. Your participation will involve regular follow-ups until the study concludes.

    At the end of the study, the results will be analyzed to determine the effectiveness of the medication in improving the prognosis of patients with advanced chronic liver disease.

Who can join the trial?

5 criteria

  • Patients of both sexes with **chronic liver disease** diagnosed by a test called **hepatic stiffness by transition elastography** showing a result greater than 15 kPa.
  • Age between 18 and 80 years, including both ages.
  • No previous or current **decompensation** (this means the liver disease has not worsened or caused serious symptoms).
  • Women who can have children must take a **pregnancy test** before starting the study. If not pregnant, they must use an effective **contraceptive method** during the study and for a short time after it ends.
  • Sign the **informed consent** form, which means you agree to participate in the study after understanding all the details.

Who cannot join the trial?

1 criterion

  • Patients with **chronic liver disease** cannot participate. This means if you have a long-term liver condition, you are not eligible.
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Investigated drugs

Zinc Acexamate is a medication being tested in this clinical trial to see if it can help people with advanced chronic liver disease. It is taken by mouth and is thought to work by providing zinc, which is an important mineral for the body. The trial is looking to see if taking this medication can improve the health of patients by reducing the number of health problems they might experience due to their liver condition.

What is already known about the treatment

Zinc Acexamate – Zinc Acexamate is administered orally in the form of tablets, with a daily dose of 600mg, which provides 100mg of elemental zinc. It is currently being studied in clinical trials to determine its effectiveness in improving the prognosis of patients with advanced chronic liver disease. The main therapeutic indication for Zinc Acexamate is to potentially reduce clinical events and the risk of these events in patients with chronic liver disease. At the molecular level, zinc is believed to support liver function by reducing inflammation and oxidative stress, which can help protect liver cells from damage. Zinc Acexamate is classified pharmacologically as a zinc compound, which is used for its potential therapeutic benefits in liver health.

Investigated diseases

Chronic liver disease – Chronic liver disease refers to a range of liver conditions that persist over a long period, often leading to progressive damage. It involves the gradual destruction of liver tissue, which can result in fibrosis, where scar tissue replaces healthy liver tissue. Over time, this can progress to cirrhosis, a severe scarring of the liver that impairs its function. As the disease advances, complications such as portal hypertension, ascites, and hepatic encephalopathy may develop. The liver's ability to detoxify the blood, produce essential proteins, and regulate metabolism becomes increasingly compromised. Chronic liver disease can also increase the risk of developing hepatocellular carcinoma, a type of liver cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518242-24-00Protocol codeIC/LV/ACZ/PCHCEstimated enrolment300 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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