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Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease

NCT06449339 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2025-06-22

No results posted yet for this study

Summary

The goal of this randomised controlled trial is to evaluate the effect of carvedilol (a non-selective beta-blocker) in patients with compensated advanced chronic liver disease under clinically significant portal hypertension or the grey zone of Baveno VII criteria.

The main question it aims to answer is:

Does carvedilol reduce hepatic decompensation and mortality in these patients despite the absence of varices needing treatment.

Researchers will compare carvedilol to no carvedilol to see if carvedilol can prevent hepatic decompensation and mortality.

Participants will either take carvedilol or not taking carvedilol for 5 years with regular clinic visit for checkups and investigations, including blood tests, ultrasonography of the liver, upper gastrointestinal endoscopy, transient elastography.

Conditions

  • Portal Hypertension
  • Hepatic Decompensation
  • Advanced Chronic Liver Disease

Interventions

DRUG

Carvedilol

Patients in the NSBB arm will receive generic carvedilol. The starting dose of oral carvedilol is 6.25mg daily (to be taken once or twice per day) and can be adjusted at each scheduled visit (either by increasing the dosage or frequency of dose administration) according to patients' tolerance, as well as the blood pressure and pulse rate that the systolic blood pressure should be not lower than 90 mmHg and pulse rate not lower than 55 beats per minute. The dosage of carvedilol can also be titrated or discontinued at unscheduled visit according to patient's condition. In case carvedilol is discontinued, it can be resumed from the starting dose at next scheduled visit if there is no contraindication for carvedilol. The dose of carvedilol will be kept at 6.25-12.5mg per day unless there are additional non-hepatic indications such as arterial hypertension or cardiac disease warranting higher carvedilol dosage. The maximum allowed dose of carvedilol is 50mg daily as per drug instruction.

Sponsors & Collaborators

  • Singapore General Hospital

    collaborator OTHER

  • University of Palermo

    collaborator OTHER

  • University of Malaya

    collaborator OTHER

  • Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Royal Prince Alfred Hospital, Sydney, Australia

    collaborator OTHER

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Jimmy Che-To Lai, MB ChB · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2031-07-30
Completion
2031-07-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06449339 on ClinicalTrials.gov