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
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing You'an Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Hunan Provincial People's Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Changzhi People's Hospital Coordinator of this site? Confirm its status | Changzhi | China | Unknown status |
| Foshan Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Foshan | China | Unknown status |
| The First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Guangdong Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Panyu Central Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangzhou Eighth People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guizhou Provincial People's Hospital Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Jincheng People's Hospital Coordinator of this site? Confirm its status | Jincheng | China | Unknown status |
| Jinzhong People's Hospital Coordinator of this site? Confirm its status | Jinzhong | China | Unknown status |
| The Second Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Nanjing Second Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shanghai Public Health Clinical Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Huadong Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Taihe Hospital, Shiyan Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| The First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| The Second Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai Coordinator of this site? Confirm its status | Zhuhai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.