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Multicenter, randomized, double-blind, comparative clinical trial to assess the efficacy of Zinc Acexamate versus a placebo in improving the prognosis of patients with advanced chronic liver disease (cACLD).
EU CTIS ID: 2024-518242-24-00
What this study is testing
To evaluate whether the oral administration of zinc acexamate (ACZ) at a dose of 600mg/day (equivalent to 100mg/day of elemental zinc) to patients with cACLD, improves your prognosis by reducing expected clinical events and the risk of suffering from them during during study follow-up.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of both sexes with cACLD diagnosed by hepatic stiffness by transition elastography >15 kPa.
- Age between 18 and 80 years, both inclusive.
- Absence of previous or current decompensation.
- In women of childbearing age, a possible pregnancy will be ruled out by means of a pregnancy test prior to the start of the study. Once the test has been carried out, the woman must use an effective contraceptive method during sexual intercourse to be maintained from the days prior to the start of treatment, and will continue to use them while the treatment is ongoing, as well as until a few days after finishing it.
- Sign the informed consent.
You likely can't join if
- History or current presence of hepatocarcinoma.
- Concomitant systemic disease, with low short-term prognosis for life.
- Pregnancy, breastfeeding, or refusal to use contraceptive measures whilst participating in the study.
- Patients with cACLD due to HBV on antiviral treatment and with cACLD due to HCV cured with antiviral treatment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.