Clinical Characteristics of Recompensation (NCT07651683) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Characteristics of Recompensation
China300 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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):
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of recompensation
Timeframe: 1 year
Trial details
NCT IDNCT07651683
SponsorThird Affiliated Hospital, Sun Yat-Sen University
. 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).