compensated advanced chronic liver disease MedDRA version: 20.1 Level: LLT Classification code 10001422 Term: Advanced chronic liver disease System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Trade Name: Copinal 300 mg cápsulas
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Zinc acexamate
CAS Number: 70020-71-2
Current Sponsor code: ACZ
Other descriptive name: ZINC ACEXAMATE
Conce
Sponsors
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Notes: Patients with esophageal varices at baseline endoscopy should be treated prophylactically with beta-blockers (preferably carvedilol) and may be included if they meet the inclusion criteria. Patients who present or have a high probability of presenting CSPH may be treated with beta-blockers (carvedilol preferably). The presence of CSPH is defined as: - HVPH = 10 mm Hg - Presence of collateral circulation in imaging tests - Liver stiffness by transition elastography =25 kPa. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess whether the administration of ACZ improves the risk of first decompensation and what type. To assess whether it reduces the overall risk of clinically significant portal hypertension [CSPH] estimated by the model described Assess whether it improves the risk of hepatocarcinoma. To study if it reduces the risk of bacterial infections. To assess whether it improves overall transplant-free survival. Assess whether it improves transplant-free survival in relation to liver-related deaths. Assess whether liver function improves as measured by the Child-Pugh score and the MELD scale. To assess whether the effects on the main variable or on each of the secondary variables separately, correlate with blood zinc levels during treatment. To evaluate the possible adverse effects of treatment with ACZ.;Main Objective: 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.;Primary end point(s): Occurrence of time-dependent clinical events during study follow-up, along with the distribution of CSPH risk estimated by the ANTICIPATE model. Clinical events are defined as the sum of: 1. Hepatic decompensation defined as the presence of clinical ascites, gastrointestinal bleeding due to portal hypertension, and hepatic encephalopathy. 2. Hepatocellular carcinoma. 3. Death from liver causes (considering non-hepatic death as a competitive risk). 4. Liver transplant.;Timepoint(s) of evaluation of this end point: The clinical follow-up will be every 3 months during the first 2 years, and then every 6 months until the end of the stud. Specific tests will be every 12 months and routine tests every 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary variables will consist of the evolutionary development of each of the secondary objectives;Timepoint(s) of evaluation of this end point: The clinical follow-up will be every 3 months during the first 2 years, and then every 6 months until the end of the study. Specific tests will be every 12 months and routine tests every 6 months. | — |
Countries
Spain
Contacts
Public ContactJoan Genescà
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Outcome results
None listed