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Clinical Trials in China / NCT07651683
Active, not recruiting Observational

Clinical Characteristics of Recompensation

NCT07651683 · tracked via the Priya Life Science China tracker
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Phase
Observational
Started
2026-03-31
Last updated
2026-06-16

Condition(s) studied

CirrhosisAlcohol Related Liver DiseaseHBV (Hepatitis B Virus)Recompensation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age: Patients aged 18 to 75 years. 2. Diagnosis of Cirrhosis: Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, hematological, radiological (CT/MRI/Ultrasound), or histological evidence. 3. 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. 4. Intervention/Management: Currently receiving or initiating nucleos(t)ide analogue (NA) antiviral therapy (for HBV cohort), or having initiated alcohol abstinence (for Alcohol cohort). 5. Index Decompensation: Presenting with esophagogastric variceal bleeding (EVB) as the first and only decompensating event at enrollment. Exclusion Criteria: 1. 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). 2. 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). 3. Liver Function Status: Child-Turcotte-Pugh (CTP) score \> 12. Malignancy: Diagnosis of hepatocellular carcinoma (HCC) or other extrahepatic malignancies. 4. Organ Failure: Severe dysfunction or failure of extrahepatic organs (e.g., severe cardiac, respiratory, or renal failure not attributed to liver disease).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Third Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07651683 on ClinicalTrials.gov ↗ ← All trials in China