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CirrhosisNCT07042308

Natural History of Advanced Chronic Liver Diseases

An observational study of Cirrhosis and Advanced Chronic Liver Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This is a retrospective-prospective registry cohort study. Patients with advanced chronic liver disease (ACLD) will be prospectively invited to this study. The study follow-up duration will be 10 years. The primary outcome is incident hepatic events and liver-related mortality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cirrhosis, Advanced Chronic Liver Disease
What is being tested?
Transient elastography
How many people
500 participants
Where
1 siteHong Kong
Study dates
25 Sep 2024to Dec 2035
How long will I take part?
10 Years
Phase
Observational

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The prospective cohort will comprise of consecutive patients with advanced chronic liver disease attending hepatology clinics or in-patient care in Prince of Wales Hospital in Hong Kong. All patients will be screened if the eligibility criteria are fulfilled.

Who may be able to join

  • Aged 18 or above
  • Known ACLD, defined by:
  • LSM > 10kPa or
  • Clinical cirrhosis, suggested by 1. ultrasonography of the hepatobiliary system shows features of cirrhosis (e.g. shrunken and nodular liver) and portal hypertension (e.g. dilated portal vein, portal-systemic collaterals or varices, splenomegaly, ascites). 2. Oesophagogastroduodenoscopy (OGD) shows presence of oesophageal varices (OV) and/or gastric varices (GV) and/or portal hypertensive gastropathy.

Who cannot join

  • Current or past history of hepatocellular carcinoma (HCC)
  • History of liver transplantation
  • Asplenism or history of splenectomy
  • Serious medical illness with limited life expectancy of less than 6 months
  • Pregnancy
  • Unable to obtain or refusal of informed consent from patient

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jimmy CT Lai, MB ChB contact

85235054205

jimmyctlai@cuhk.edu.hk

Angel Chim, MSc contact

85235054205

angelchim@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Prince of Wales Hospital

    Hong Kong

    Jimmy CT Lai, MB ChB, 85235054205, jimmyctlai@cuhk.edu.hk

    Angel Chim, MSc, 85235054205, angelchim@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Natural History of Advanced Chronic Liver Diseases and Factors Associated With Hepatic Events - a Registry Study

This is a retrospective-prospective registry cohort study. Patients with advanced chronic liver disease (ACLD) will be prospectively invited to this study. The study follow-up duration will be 10 years. The primary outcome is incident hepatic events and liver-related mortality. Participants will undergo annual transient elastography examination.

Read the detailed description

Chronic liver diseases (CLD) has burdened the global healthcare system throughout the years. Among all causes of CLD, chronic hepatitis B (CHB) is generally the commonest cause of CLD in the Asia-Pacific region but the prevalence is expected to decline due to effective antiviral treatment. Similarly, with the introduction of direct-acting antiviral (DAA), chronic hepatitis C (CHC) is now readily curable. On the other hand, an increasing trend is observed in metabolic dysfunction-associated steatotic liver disease (MASLD) and alcohol-related liver disease (ARLD) which is likely to change the landscape of CLD both in the region and worldwide.

Advanced chronic liver disease (ACLD) or cirrhosis is a final common pathway of all CLD and was the 9th and 15th leading cause of death in Southeast Asia (0.42 million deaths) in 2019 as reported by the World Health Organization (WHO) Global Health Estimates. It also significantly increases the risk of hepatocellular carcinoma (HCC). With its significant impact on morbidity and mortality, the prognosis of compensated and decompensated states differ drastically and the field is pushing forward ways to prevent hepatic decompensation in order to improve liver-related outcomes. Non-selective beta-blockers (NSBB) has been shown to reduce risk of hepatic decompensation in patients with compensated advanced chronic liver disease (cACLD) and concomitant clinically significant portal hypertension (CSPH). Some other drugs including angiotensin converting enzyme inhibitor (ACEI)/angiotensin-receptor blocker (ARB), statin etc. have been shown in retrospective studies to reduce risk of hepatic decompensation but more evidence is required to draw conclusive interpretation.

Apart from medications, non-invasive tests (NIT), including liver stiffness measurement (LSM) and spleen stiffness measurement (SSM) from vibration-controlled transient elastography (VCTE) help prognosticate chronic liver diseases. Yet more validation is required on certain conditions such as in patients with obesity as well as HCC. Biomarkers are also under the spotlights for risk prediction but are yet to reach the stage for widespread clinical practice. Hence these areas deserve further studies.

Hong Kong is an area endemic for chronic hepatitis B as well as expected for an increase with MASLD and ARLD. There has not been an established registry to capture these ACLD patients for systematic monitoring and analysis. Thus, a registry for ACLD is imperative.

Being tested
Transient elastography
Keywords
advanced chronic liver disease
Medical subject headings
Fibrosis

What participants receive

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

  • Transient elastographyDiagnostic test

    Liver stiffness and spleen stiffness from transient elastography

Study groups in NCT07042308
Study groupRoleWhat they receive
Patients with advanced chronic liver diseaseAdult patients with advanced chronic liver disease
Receives: Diagnostic Test: Transient elastography

What is being measured

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

  1. Incident hepatic events and liver-related mortality

    Incident hepatic events (including ascites, variceal bleeding and overt hepatic encephalopathy) and liver-related mortality

    Measured: 10 years

Secondary outcomes (5)
  1. Incidence rate of each hepatic event

    Hepatic events include ascites, variceal bleeding and overt hepatic encephalopathy

    Measured: 10 years

  2. Incidence rate of hepatocellular carcinoma

    Development of hepatocellular carcinoma

    Measured: 10 years

  3. Changes in Child-Pugh and Model for End-stage Liver Disease scores

    The minimum and maximum Child-Pugh score are 5 and 15, respectively. The minimum and maximum Model for End-stage Liver Disease score are 6 and 40, respectively. A higher score denotes worse outcome in both scores

    Measured: 10 years

  4. Change in liver and spleen stiffness

    Change in liver and spleen stiffness by transient elastography

    Measured: 10 years

  5. Exploratory outcome on identification of novel biomarkers

    Novel biomarkers include multi-omics exploration in relation to the primary outcome.

    Measured: 10 years

Timeline

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

  1. First posted29 Jun 2025
  2. Study start25 Sep 2024
  3. Primary completionDec 2035 (estimated)
  4. Study completionDec 2035 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07042308
Sponsor's protocol ID
2024.258
Status last verified
Oct 2026
First submitted
17 Jun 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data may be shared upon reasonable request.

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