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

Study acronym: BB_cACLD
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Collaborators revised (5)v5 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Aug 1, 2024 to Jul 17, 2024v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2024 to Jul 17, 2024
  3. Start date: Jul 1, 2024 to Aug 1, 2024 Primary endpoint revised · Primary and study completion dates: Jun 30, 2031 to Jul 30, 2031 · Eligibility criteria expanded, about 48 words · 3 morev3 Show 6 more changesShow less
    • Primary endpoint revised
    • Primary and study completion dates: Jun 30, 2031 to Jul 30, 2031
    • Eligibility criteria expanded, about 48 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description revised
    • Publications: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  4. Secondary endpoints: 6 to 7v2 See this version in full on ClinicalTrials.gov ↗
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06449339
Lead Sponsor Chinese University of Hong Kong
Collaborators: Singapore General Hospital, University of Palermo, University of Malaya, Shanghai Jiao Tong University School of Medicine, Royal Prince Alfred Hospital, Sydney, Australia
Conditions Portal Hypertension, Hepatic Decompensation, Advanced Chronic Liver Disease
Enrollment 474 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov