Clinical Characteristics of Recompensation

NCT07651683 | Active Not Recruiting

• 1 other identifier: ZSSYXHNK2601
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cirrhosis; Alcohol Related Liver Disease; HBV (Hepatitis B Virus); Recompensation

Keywords

Cirrhosis; Alcohol-related liver disease; Hepatitis B virus; Recompensation

Outcome Measures

Primary Outcomes (1)

• Rate of recompensation

  1 year

Study Arms (2)

HBV-related cirrhosis cohort

Patients 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 cohort

Patients with alcohol-associated cirrhosis managed at Third Affiliated Hospital, Sun Yat-Sen University between March 2022 and December 2024 were retrospectively identified for inclusion.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Fibrosis; Hepatitis B

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bin Wu

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: June 16, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)