Table of contents
- Trial overview
- Who can participate
- Study design and phase
- What is being measured
- Study treatment and comparison
- Why this trial matters
Trial overview
The available clinical trial is a multicenter, randomized, double-blind, comparative clinical trial studying Zinc Acexamate in people with advanced chronic liver disease (cACLD).[1] The study is designed to check whether Zinc Acexamate can improve prognosis and reduce serious liver-related events during follow-up.[1]
The trial is authorised and planned for 300 participants.[1] It is a Phase 3 study, which means it is testing the treatment in a larger group of patients and looking carefully at outcomes.[1]
Who can participate
The target population in the trial data is patients with chronic liver disease, specifically advanced chronic liver disease (cACLD).[1] No more detailed inclusion or exclusion rules are provided in the source data, so the main known requirement is the disease group being studied.[1]
This means the study is focused on adults with more advanced liver disease, rather than on healthy volunteers or people with other conditions.[1]
Study design and phase
The study uses a randomized design, so participants are assigned by chance to a study group.[1] This helps make the comparison fair and reduces the chance that the results are influenced by who receives which treatment.[1]
It is also double-blind, which means neither the participants nor the study team know who is receiving Zinc Acexamate and who is receiving placebo during the trial.[1] This helps reduce bias, which is when expectations could affect how results are seen or reported.[1]
The trial is interventional, meaning researchers assign a treatment and then observe the results.[1] It is being carried out at multiple sites, which can help include a broader patient population and make the results more generalizable.[1]
What is being measured
The main endpoint is the occurrence of time-dependent clinical events during follow-up.[1] An endpoint is the main result the researchers use to judge whether the treatment is helping.[1]
The clinical events being tracked include hepatic decompensation, which the trial defines as clinical ascites, gastrointestinal bleeding due to portal hypertension, and hepatic encephalopathy.[1] Ascites means fluid buildup in the belly, and hepatic encephalopathy means brain problems caused by liver disease.[1]
Other events being measured are hepatocellular carcinoma, death from liver causes, and liver transplant.[1] The trial also looks at the distribution of CSPH risk estimated by the ANTICIPATE model.[1] CSPH stands for clinically significant portal hypertension, which means important high pressure in the blood flow to the liver.[1]
Study treatment and comparison
The study compares Zinc Acexamate with a placebo, which is a look-alike treatment without the active substance.[1] The source data also says the trial uses oral administration and describes the study drug as COPINAL 300 mg capsules at 600 mg per day, equivalent to 100 mg per day of elemental zinc.[1]
The purpose of this comparison is to see whether Zinc Acexamate leads to fewer serious liver events and a better prognosis than placebo in patients with cACLD.[1]
Why this trial matters
People with advanced chronic liver disease can face serious outcomes, including liver failure, liver cancer, transplant, or death from liver causes.[1] This trial is important because it focuses on whether Zinc Acexamate can change those outcomes in a meaningful way.[1]
Because the study is Phase 3 and uses a placebo comparison, it is designed to give stronger evidence about benefit in a real patient group with advanced liver disease.[1] The results may help show whether the treatment can lower the risk of major clinical events over time.[1]
