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Advanced Chronic Liver DiseasePhase 3NCT06434753

Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease.

A Phase 3 study testing Zinc Acexamate in people with Advanced Chronic Liver Disease and Portal Hypertension, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Zinc homeostasis could play a role in advanced chronic liver disease (cACLD) and its supplementation has been linked with improvement in liver function, decrease of hepatic complications and reduction in hepatocellular carcinoma (HCC) incidence. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Zinc Acexamate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteSpain
Study dates
2 Oct 2022to 2 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients of both sexes with diagnosed compensated advanced chronic liver disease (cACLD) determined by hepatic stiffness on transient elastography >15 kPa.
  • Age between 18 and 80 years, inclusive.
  • Absence of prior or current decompensation.
  • For women of childbearing age, a possible pregnancy will be ruled out by a pregnancy test prior to the start of the study. Following the test, the woman must use an effective contraceptive method during sexual intercourse (see Appendix I) in the days leading up to the start of treatment, and continue to use it throughout the treatment period, as well as for several days after its completion.
  • Signing of informed consent.

Who cannot join

  • History or current presence of hepatocellular carcinoma.
  • Concomitant systemic disease with a short-term poor prognosis.
  • Pregnancy, breastfeeding, or refusal to use contraceptive measures during participation in the study.
  • Patients with compensated advanced chronic liver disease (cACLD) due to hepatitis B virus (HBV) under antiviral treatment, and those with cACLD due to hepatitis C virus (HCV) cured with antiviral treatment.

Trial locations and contacts

1 site in 1 country.

Joan Genescá, MD, PhD contact

934 89 30 00

joan.genesca@vallhebron.cat

Spain1 site, 1 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Joan Genescá, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease: A Multicenter, Randomized, Double-blind, Placebo Controlled Clinical Trial

Zinc homeostasis could play a role in advanced chronic liver disease (cACLD) and its supplementation has been linked with improvement in liver function, decrease of hepatic complications and reduction in hepatocellular carcinoma (HCC) incidence. cACLD encompasses a heterogeneous group of patients with a variable risk of clinically significant portal hypertension (CSPH) and clinical events. The ANTICIPATE model is a validated model for stratifying these risks. Our aim is to demonstrate that the administration of zinc can reduce the rate and risk of presenting clinical events (first decompensation, HCC, death and liver transplantation). This study protocol describes an ongoing phase III, national, multicentre, randomized, double-blind clinical trial that will enroll 300 patients to receive either the trial treatment (zinc acexamate) or placebo. An inclusion period of 42 months is planned, with a minimal duration of follow up of 2 years. Our principal hypothesis is that zinc could modify the natural history of cACLD patients, with an overall improvement in prognosis

Being tested
Zinc Acexamate
Medical subject headings
Hypertension, Portal, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zinc AcexamateDrug

    Also called Placebo

    The experimental group will receive ACZ at a daily dose of 600 mg, equivalent to 100mg of elemental zinc (one hard gelatin capsule of 300 mg of ACZ twice a day). Treatment will be stopped when the patient presents any of the events that define the main endpoint of the study.

    The control group will receive twice a day orally hard gelatin capsules, identical to those of ACZ, in color, weight and nature, but containing an inert preparation (isomaltose).

Study groups in NCT06434753
Study groupRoleWhat they receive
Zinc AcexamateExperimentalThe experimental group will receive ACZ at a daily dose of 600 mg, equivalent to 100mg of elemental zinc (one hard gelatin capsule of 300 mg of ACZ twice a day). Treatment will be stopped when the patient presents any of the events that define the main endpoint of the study.
Receives: Drug: Zinc Acexamate
PlaceboPlacebo comparatorThe control group will receive twice a day orally hard gelatin capsules, identical to those of ACZ, in color, weight and nature, but containing an inert preparation (isomaltose).
Receives: Drug: Zinc Acexamate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Values 1-6. Ordinal scale to assess efficacy of the intervention.

    Ordinal scale to assess efficacy of the intervention, with expected distribution of patients on each study arm at the 2-year mark, based on an effect size of an OR of 0.55.The most severe category (Value 6) will be the development of clinical events:First decompensation,hepatocellular carcinoma, liver related-death (non-liver-related deaths as competing events), and liver transplantation.Those patients free of a liver-related event at 2 years,will be classified according to the risk of CSPH (ANTICIPATE model value), distributing patients in the ordinal scale with ascending hierarchy of CSPH risk: Level 1,<0.30 risk;Level 2,0.30-0.45 risk;Level 3, 0.45-0.60 risk;Level 4, 0.60-0.85 risk;and Level 5, >0.85 risk.

    Expected clinical events at 2 years of follow-up (PREDESCI study and others on natural history of liver cirrhosis) with added effect of decompensation, HCC and death:20% of clinical events at 2 years (16% decompensations,2% hepatocellular carcinomas and 2% deaths).

    Measured: 24 months

  2. Time-dependent composite clinical endpoint

    Time to occurrence of the composite endpoint of only clinical events until study termination.

    Measured: End of Follow-up

Secondary outcomes (6)

  1. Evaluate if the administration of zinc decreases the risk of having the first decompensation and what type.

    Number of descompensations: First descompensation, hepatocellular carcinoma, liver related-death, liver transplantation.

    Measured: 24 months

  2. Evaluate if the administration of zinc decreases the risk of CSPH estimated by the ANTICIPATE model.

    Odds Ratio

    Measured: 24 months

  3. Evaluate if the administration of zinc reduces the risk of hepatocellular carcinoma.

    Odds Ratio

    Measured: 24 months

  4. Evaluate if the administration of zinc reduces the risk of bacterial infections.

    Odds Ratio

    Measured: 24 months

  5. Evaluate if the administration of zinc improves overall transplant-free survival and the risk of liver-related death.

    Odds Ratio

    Measured: 24 months

  6. Evaluate if the administration of zinc improves liver function as measured by Child-Pugh and End-stage Liver Disease (MELD) score.

    Child-Pugh: 5 (better outcome) to 15 (worse outcome). Child- Pugh has not an unabbreviated title. MELD: 6 (better outcome) to 40 (worse outcome)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start2 Oct 2022
  3. Primary completion2 Mar 2026 (estimated)
  4. Study completion2 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase III, randomized, double-blind clinical trial with two parallel groups, controlled with placebo. This is a low-level intervention clinical trial since the experimental drug is an authorized medication. This is a multicenter national study with fifteen Spanish centers recruiting patients
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06434753
Sponsor's protocol ID
IC/LV/ACZ/PCHC
Status last verified
Jun 2024
First submitted
30 Apr 2024
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Banares J, Aceituno L, Ruiz-Ortega L, Pons M, Abraldes JG, Genesca J. Zinc supplementation to improve prognosis in patients with compensated advanced chronic liver disease: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Hepatol Commun. 2024 Oct 10;8(11):e0524. doi: 10.1097/HC9.0000000000000524. eCollection 2024 Nov 1.

    PubMed 39392768

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zinc Acexamate in people with Advanced Chronic Liver Disease and Portal Hypertension, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joan Genescá, MD, PhD (934 89 30 00, joan.genesca@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Values 1-6. Ordinal scale to assess efficacy of the intervention. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06434753, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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