NCT07651683Active, not recruiting
Clinical Characteristics of Recompensation
Clinical Characteristics and Outcomes of Recompensation in Decompensated Cirrhosis
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 30 Mar 2026
- Start date
- Mar 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Hepatitis B
- NCT number
- NCT07651683
What you commit to
- Study type: Observational
- Planned participants: 300
- From Mar 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Third Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.