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.
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.
Hong Kong1 site, 1 recruiting
- 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
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.
- Conditions
- Cirrhosis, Advanced Chronic Liver Disease
- 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 group | Role | What they receive |
|---|---|---|
| Patients with advanced chronic liver disease | Adult 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.
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)
Incidence rate of each hepatic event
Hepatic events include ascites, variceal bleeding and overt hepatic encephalopathy
Measured: 10 years
Incidence rate of hepatocellular carcinoma
Development of hepatocellular carcinoma
Measured: 10 years
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
Change in liver and spleen stiffness
Change in liver and spleen stiffness by transient elastography
Measured: 10 years
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.
- First posted29 Jun 2025
- Study start25 Sep 2024
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimmy Che-To Lai, Chinese University of Hong Kong
- Investigators
- Jimmy CT Lai, MB ChB, Principal investigator, Chinese University of Hong Kong
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.