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NCT07087041Not yet recruiting

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

Prediction of Recompensation and Stable Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness Combined With Non-Invasive Markers: A Prospective, Observational, Multicenter Study

Source: ClinicalTrials.gov · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
735 (estimated)
First submitted
4 Jul 2025
Start date
15 Jul 2025
Primary completion date
30 Oct 2028
Lead sponsor
Beijing Friendship Hospital
NCT number
NCT07087041

What you commit to

  • Study type: Observational
  • Planned participants: 735
  • From 15 Jul 2025 to the primary completion date, 30 Oct 2028
  • 28 sites 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

  • Prior orthotopic liver transplantation or TIPS
  • Prior splenectomy, splenic embolization, or other shunt surgery

Other illness

  • Acute variceal bleeding within the last 4 weeks or unstable condition
  • 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)

Other

  • Missing data on first decompensated event
  • History or current diagnosis of hepatocellular carcinoma
  • Uncontrolled moderate-to-severe ascites
  • Pregnant or breastfeeding women

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing You'an Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Ditan Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
Hunan Provincial People's Hospital
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ChangshaChinaUnknown status
Changzhi People's Hospital
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ChangzhiChinaUnknown status
Foshan Traditional Chinese Medicine Hospital
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FoshanChinaUnknown status
The First People's Hospital of Foshan
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FoshanChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Mengchao Hepatobiliary Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Guangdong Provincial Hospital of Chinese Medicine
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GuangzhouChinaUnknown status
Panyu Central Hospital
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GuangzhouChinaUnknown status
Nanfang Hospital, Southern Medical University
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GuangzhouChinaUnknown status
Guangzhou Eighth People's Hospital
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GuangzhouChinaUnknown status
Guizhou Provincial People's Hospital
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GuiyangChinaUnknown status
Jincheng People's Hospital
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JinchengChinaUnknown status
Jinzhong People's Hospital
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JinzhongChinaUnknown status
The Second Hospital of Lanzhou University
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LanzhouChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
Nanjing Second Hospital
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NanjingChinaUnknown status
QingDao Municipal Hospital
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QingdaoChinaUnknown status
Shanghai Public Health Clinical Center
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ShanghaiChinaUnknown status
Huadong Hospital, Fudan University
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ShanghaiChinaUnknown status
The First Affiliated Hospital of China Medical University
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ShenyangChinaUnknown status
Taihe Hospital, Shiyan
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ShiyanChinaUnknown status
The First Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
The Second Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai
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ZhuhaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.