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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).

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518242-24-00
Acronym
IC/LV/ACZ/PCHC
Enrollment
300
Registered
2024-10-18
Start date
2022-06-27
Completion date
Unknown
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic liver disease

Brief summary

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.

Interventions

DRUGCOPINAL 300 mg cápsulas

Sponsors

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026