A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests

NCT07087041 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Friendship Hospital

Phase

Observational

Started

2025-07-15

Last updated

2025-07-25

Condition(s) studied

Decompensated CirrhosisHepatitis B Virus (HBV) InfectionMetabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Alcohol-Related Liver DiseasePortal HypertensionRecompensation

Study summary

The goal of this observational study is to learn if spleen stiffness and other non-invasive markers can help predict recompensation in people with decompensated cirrhosis who are receiving effective treatment for the cause of their liver disease. The main questions it aims to answer are:

* Can spleen stiffness and blood test results predict who will get better and stay better after cirrhosis becomes worse?
* What are the features of people who recover after decompensation?

Participants will:

* Be people with decompensated cirrhosis who are already getting effective treatment (such as antiviral therapy or alcohol abstinence)
* Be followed over time to check if they remain stable or have more liver problems
* Have non-invasive tests done, including spleen stiffness measurement and blood tests

Researchers will track how many participants recover and stay recovered over time, and use that information to build a tool to help predict outcomes in others with cirrhosis.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Male or female, aged 18 to 75 years (inclusive) * Clinically diagnosed decompensated cirrhosis * First decompensated event occurred within 12 months of screening, or no decompensated events in the past 12 months despite a history of decompensation * Received effective etiological treatment per guidelines: * For HBV: Sustained antiviral suppression * For alcohol-related liver disease: Sustained abstinence for ≥2 months * For MAFLD-related cirrhosis: Improved liver function after lifestyle/ metabolic intervention Exclusion Criteria: * Missing data on first decompensated event * Prior orthotopic liver transplantation or TIPS * Prior splenectomy, splenic embolization, or other shunt surgery * History or current diagnosis of hepatocellular carcinoma * Acute variceal bleeding within the last 4 weeks or unstable condition * Uncontrolled moderate-to-severe ascites * Cholestatic cirrhosis; untreated chronic liver diseases; non-cirrhotic portal hypertension; vascular liver diseases (e.g., Budd-Chiari syndrome) * Acute or chronic portal vein thrombosis * Severe comorbidities of heart, lung, kidney, brain, hematologic, or psychiatric systems * Other systemic malignancies (except cured cases) * Pregnant or breastfeeding women

Primary outcome measure(s)

Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation — 2 years
The primary outcome of this study is the accuracy of a non-invasive prediction model based on spleen stiffness and routine laboratory markers in identifying recompensation and stable recompensation in individuals with decompensated cirrhosis.

Trial sites (28)

Facility	City	Region
Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing Municipality
Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing Municipality
Beijing You'an Hospital, Capital Medical University	Beijing	Beijing Municipality
The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
Mengchao Hepatobiliary Hospital of Fujian Medical University	Fuzhou	Fujian
The Second Hospital of Lanzhou University	Lanzhou	Gansu
Foshan Traditional Chinese Medicine Hospital	Foshan	Guangdong
The First People's Hospital of Foshan	Foshan	Guangdong
Guangzhou Eighth People's Hospital	Guangzhou	Guangdong
Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong
Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
Panyu Central Hospital	Guangzhou	Guangdong
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai	Zhuhai	Guangdong
Guizhou Provincial People's Hospital	Guiyang	Guizhou
Taihe Hospital, Shiyan	Shiyan	Hubei
Hunan Provincial People's Hospital	Changsha	Hunan
Xiangya Hospital, Central South University	Changsha	Hunan
Nanjing Second Hospital	Nanjing	Jiangsu
The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
Qingdao Municipal Hospital	Qingdao	Shandong
Huadong Hospital, Fudan University	Shanghai	Shanghai Municipality
Shanghai Public Health Clinical Center	Shanghai	Shanghai Municipality
Changzhi People's Hospital	Changzhi	Shanxi
Jincheng People's Hospital	Jincheng	Shanxi
Jinzhong People's Hospital	Jinzhong	Shanxi
The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi

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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 NCT07087041 on ClinicalTrials.gov ↗ ← All trials in China