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NCT Number: NCT07042308

Natural History of Advanced Chronic Liver Diseases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Transient elastography

Diagnostic Test

Liver stiffness and spleen stiffness from transient elastography

Primary outcomes

  1. Incident hepatic events and liver-related mortality

    Time frame: 10 years

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

Secondary outcomes

  1. Incidence rate of each hepatic event

    Time frame: 10 years

    Hepatic events include ascites, variceal bleeding and overt hepatic encephalopathy

  2. Incidence rate of hepatocellular carcinoma

    Time frame: 10 years

    Development of hepatocellular carcinoma

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

    Time frame: 10 years

    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

  4. Change in liver and spleen stiffness

    Time frame: 10 years

    Change in liver and spleen stiffness by transient elastography

  5. Exploratory outcome on identification of novel biomarkers

    Time frame: 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Angel Chim, MSc

CONTACT

[email protected]

85235054205

Jimmy CT Lai, MB ChB

CONTACT

[email protected]

85235054205

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2035
Study completion
2035
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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