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CirrhosisNCT07651683

Clinical Characteristics of Recompensation

An observational study of Cirrhosis and Alcohol Related Liver Disease, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Recompensation in decompensated liver cirrhosis is an emerging clinical endpoint; however, standardized criteria and long-term prognostic data are currently lacking. This retrospective study aims to address these gaps by analyzing a cohort of patients with HBV-related and alcohol-related cirrhosis. Read more about this study

Who is it for?
Ages 18 to 75 years
How many people
300 participants
Where
1 siteChina
Study dates
31 Mar 2026to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with hepatitis B virus (HBV)-related cirrhosis and alcohol-associated cirrhosis managed at Third Affiliated Hospital, Sun Yat-Sen University between March 2022 and December 2024 were retrospectively identified for inclusion.

Who may be able to join

  • Age: Patients aged 18 to 75 years.
  • Diagnosis of Cirrhosis: Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, hematological, radiological (CT/MRI/Ultrasound), or histological evidence.
  • Specific Etiology (Must meet one of the following):
  • HBV-related: Documented Hepatitis B surface antigen (HBsAg) positivity. Alcohol-related: Documented history of significant alcohol intake or recent heavy alcohol consumption (within the past 2 weeks) combined with HBsAg negativity and radiological evidence of hepatic steatosis.
  • Intervention/Management: Currently receiving or initiating nucleos(t)ide analogue (NA) antiviral therapy (for HBV cohort), or having initiated alcohol abstinence (for Alcohol cohort).
  • Index Decompensation: Presenting with esophagogastric variceal bleeding (EVB) as the first and only decompensating event at enrollment.

Who cannot join

  • Concomitant Liver Disease: Evidence of other coexisting etiologies of chronic liver disease (e.g., Hepatitis C virus infection, autoimmune liver disease, drug-induced liver injury, or parasitic liver disease).
  • Prior Decompensation: Current presence or prior history of other decompensation events, specifically moderate-to-severe ascites (grade 2 or 3), hepatic encephalopathy (HE), hepatorenal syndrome (HRS), or hepatopulmonary syndrome (HPS).
  • Liver Function Status: Child-Turcotte-Pugh (CTP) score > 12. Malignancy: Diagnosis of hepatocellular carcinoma (HCC) or other extrahepatic malignancies.
  • Organ Failure: Severe dysfunction or failure of extrahepatic organs (e.g., severe cardiac, respiratory, or renal failure not attributed to liver disease).

Trial locations and contacts

1 site in 1 country.

China1 site
  • Third Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Clinical Characteristics and Outcomes of Recompensation in Decompensated Cirrhosis

Recompensation in decompensated liver cirrhosis is an emerging clinical endpoint; however, standardized criteria and long-term prognostic data are currently lacking. This retrospective study aims to address these gaps by analyzing a cohort of patients with HBV-related and alcohol-related cirrhosis.

This retrospective cohort study aims to validate established recompensation criteria and propose new standards for defining stable liver function.

Read more

Additionally, the study will characterize the natural history of recompensated patients by tracking the duration of recompensation, incidence of hepatocellular carcinoma, and liver-related mortality. Statistical analysis will be performed to identify baseline predictors for achieving recompensation and to determine risk factors for subsequent re-decompensation events.

Identify Predictors: Analyze baseline characteristics to identify independent predictors for achieving recompensation.

Evaluate Risks: Investigate risk factors associated with re-decompensation in patients who have successfully achieved recompensation.

Read the detailed description
  1. Background and Epidemiology Cirrhosis remains a leading cause of morbidity and global mortality, with a disproportionately high burden in the Asia-Pacific region. According to WHO data, the Asia-Pacific region accounts for nearly half of global cirrhosis-related deaths, driven primarily by Hepatitis B virus (HBV) infection and alcohol-associated liver disease (ALD). While antiviral therapies (e.g., nucleoside/nucleotide analogues) for HBV and abstinence for ALD have been shown to slow disease progression and improve survival, the clinical trajectory of patients who present with decompensated cirrhosis has traditionally been considered irreversible.
  2. The Concept of Recompensation Historically, decompensated cirrhosis was viewed as a terminal stage with a median survival of 2-4 years. However, emerging evidence suggests that effective etiological treatment can lead to "recompensation"-a distinct clinical state characterized by the resolution of decompensation events and functional liver recovery. The Baveno VII consensus provided the first standardized definition of recompensation, requiring: Removal, suppression, or cure of the primary etiology; Resolution of ascites, hepatic encephalopathy, and variceal bleeding for at least 1 year without specific supportive treatments (e.g., diuretics); Sustained improvement in liver function (though specific cut-off values for parameters like albumin and INR remain to be fully defined).
  3. Current Evidence and Knowledge Gaps Recent studies have begun to validate this concept. Research in HBV-related cirrhosis (e.g., Wang et al., Deng et al.) indicates that 50-80% of treated patients may achieve recompensation, correlating with reduced incidences of hepatocellular carcinoma (HCC) and improved survival comparable to compensated patients. Similarly, limited data in ALD (Benedikt et al.) suggest that recompensation is associated with hemodynamic improvements and reduced mortality. Despite these advances, significant gaps remain: Definition Ambiguity: The "stable liver function" criterion in Baveno VII lacks quantitative precision. Etiological Scope: Most data focus on HBV, with insufficient comparative data for ALD. Durability: The long-term stability of the recompensated state and the risk factors for "redecompensation" are poorly understood.
  4. Study Objectives This retrospective cohort study aims to validate established recompensation criteria and propose new standards for defining stable liver function.

Additionally, the study will characterize the natural history of recompensated patients by tracking the duration of recompensation, incidence of hepatocellular carcinoma, and liver-related mortality. Statistical analysis will be performed to identify baseline predictors for achieving recompensation and to determine risk factors for subsequent re-decompensation events.

Identify Predictors: Analyze baseline characteristics to identify independent predictors for achieving recompensation.

Evaluate Risks: Investigate risk factors associated with re-decompensation in patients who have successfully achieved recompensation.

Keywords
Cirrhosis, Alcohol-related liver disease, Hepatitis B virus, Recompensation
Medical subject headings
Fibrosis, Hepatitis B

What participants receive

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

Study groups in NCT07651683
Study groupRoleWhat they receive
HBV-related cirrhosis cohortPatients with HBV-related cirrhosis managed at Third Affiliated Hospital, Sun Yat-Sen University between March 2022 and December 2024 were retrospectively identified for inclusion.
alcohol-related cirrhosis cohortPatients with alcohol-associated cirrhosis managed at Third Affiliated Hospital, Sun Yat-Sen University between March 2022 and December 2024 were retrospectively identified for inclusion.

What is being measured

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

  1. Rate of recompensation

    Measured: 1 year

Timeline

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

  1. First posted16 Jun 2026
  2. Study start31 Mar 2026
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion31 Dec 2027 (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
Retrospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07651683
Sponsor's protocol ID
ZSSYXHNK2601
Status last verified
Jun 2026
First submitted
30 Mar 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)

Questions about this trial

What is this clinical trial studying?

An observational study of Cirrhosis and Alcohol Related Liver Disease, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of recompensation (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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