Decompensated CirrhosisLEAD-2NCT07087041
A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests
An observational study of Decompensated Cirrhosis and Hepatitis B Virus (HBV) Infection, run by Beijing Friendship Hospital at 28 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Decompensated Cirrhosis, Hepatitis B Virus (HBV) Infection, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- How many people
- 735 participants
- Where
- 28 sitesChina
- Study dates
- 15 Jul 2025to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 to 75 years with decompensated cirrhosis who are receiving and maintaining effective treatment for the underlying cause of liver disease. The first decompensation event must be clinically significant ascites and/or variceal bleeding. Participants must have either experienced their first decompensation within the past 12 months or remained free from new decompensation events during the past 12 months.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
China28 sites
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Qi Wang
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Bingqiong Wang, Dr, 86-010-63138665, 13031136358@163.com
Hong You
Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Jie Chen, Dr, 13810594713, jiechenokcat0215@126.com
Zhongjie Hu
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
Zheng Zhang
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Changzhi People's Hospital
Changzhi, Shanxi, 046000
Foshan Traditional Chinese Medicine Hospital
Foshan, Guangdong, 528000
Xiaojun Ma
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Honglian Bai
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Yueyong Zhu
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
Zuxiong Huang
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, 510060
Yujun Guan
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Junmin Jiang
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jinjun Chen
Panyu Central Hospital
Guangzhou, Guangdong, 511400
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Hong Peng
Jincheng People's Hospital
Jincheng, Shanxi, 048000
Yunlei Liang
Jinzhong People's Hospital
Jinzhong, Shanxi, 030600
Jingling Li
The Second Hospital of Lanzhou University
Lanzhou, Gansu, 730000
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Shuilin Sun
Nanjing Second Hospital
Nanjing, Jiangsu, 210003
Yongfeng Yang
Qingdao Municipal Hospital
Qingdao, Shandong, 266071
Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Yuanwen Chen
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Qingchun Fu
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Taihe Hospital, Shiyan
Shiyan, Hubei, 442000
Zhongji Meng
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Xirun Wu
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai
Zhuhai, Guangdong, 519000
Xi Liu
About this study
Official title: Prediction of Recompensation and Stable Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness Combined With Non-Invasive Markers: A Prospective, Observational, Multicenter Study
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?
Read more
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.
Read the detailed description
This is a prospective, observational, multicenter study designed to follow adults with decompensated cirrhosis who are receiving effective treatment for the underlying cause of their liver disease, such as antiviral therapy, alcohol abstinence, or metabolic management. The study is aiming to understand how these patients recover after treatment; Identify how often they achieve recompensation and stable recommendation; Develop a non-invasive model using spleen stiffness and other markers to predict who is more likely to improve.
Participants will be grouped based on whether they have had decompensation within the past 12 months. Researchers will regularly collect clinical data, spleen stiffness measurements, and lab tests, to develop and validate a model that predicts recompensation and stable recompensation. The study will also assess the cumulative incidence of clinical events (e.g., further decompensation, hepatocellular carcinoma, liver transplantation, and death) over a two-year follow-up period. Predictive accuracy, model calibration, and discrimination will be evaluated using standard statistical methods, including competing risk models and AUROC analysis.
- Conditions
- Decompensated Cirrhosis, Hepatitis B Virus (HBV) Infection, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Alcohol-Related Liver Disease, Portal Hypertension, Recompensation
- Keywords
- Recompensation, Decompensated Cirrhosis, Spleen Stiffness
- Medical subject headings
- Hepatitis B, Infections, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recompensation group | ≥12 months since the last decompensated event | |
| Non-recompensation group | <12 months since the last decompensated event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation
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.
Measured: 2 years
Secondary outcomes (8)
Discrimination, calibration, and stability of the prediction model
This outcome assesses the performance of the prediction model developed to identify recompensation and stable recompensation in people with decompensated cirrhosis.
Measured: 2 years
Predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation
This outcome evaluates the predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.
Measured: 2 years
Predictive accuracy of liver stiffness in identifying recompensation and stable recompensation
This outcome evaluates the predictive accuracy of liver stiffness in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.
Measured: 2 years
Predictive accuracy of platelets in identifying recompensation and stable recompensation
This outcome evaluates the predictive accuracy of platelet count in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.
Measured: 2 years
Cumulative incidence of recompensation by etiology
This outcome measures the 2-year cumulative incidence of recompensation among participants with decompensated cirrhosis, stratified by the underlying cause of liver disease (etiology). Recompensation is defined as the effective control or removal of the primary cause of liver disease, resolution of ascites and hepatic encephalopathy with no episodes of variceal bleeding for at least 12 months, and improvement in liver function indicated by a Child-Pugh classification of Class A and/or a MELD score below 10.
Measured: 2 years
Cumulative incidence of stable recompensation by etiology
This outcome measures the 2-year cumulative incidence of stable recompensation in participants with decompensated cirrhosis, stratified by liver disease etiology. Stable recompensation is defined as achieving recompensation and maintaining that status without further decompensated events for at least one additional year.
Measured: 2 years
Cumulative incidence of further decompensation by etiology
This outcome evaluates the 2-year cumulative incidence of further decompensation among participants with decompensated cirrhosis, stratified by the underlying etiology of liver disease. Further decompensation is defined as the occurrence of new or worsening clinical events such as ascites, hepatic encephalopathy, or variceal bleeding after initial enrollment.
Measured: 2 years
Cumulative incidence of liver-related composite endpoints by etiology
This outcome assesses the 2-year cumulative incidence of liver-related composite endpoints among participants with decompensated cirrhosis, stratified by liver disease etiology.Liver-related composite endpoints include the first occurrence of any of the following events: Further hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy); Hepatocellular carcinoma (HCC); Liver transplantation; Liver-related death.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 735 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
- Investigators
- Hong You, Prof., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087041
- Sponsor's protocol ID
- 2025-P2-244-01
- Acronym
- LEAD-2
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data to be shared include de-identified demographic information, clinical characteristics, laboratory test results (including spleen stiffness, liver stiffness, platelet counts, and other routine blood tests), treatment details, and clinical outcomes related to recompensation and stable recompensation.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Recompensation and Stable Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness Combined With Non-Invasive Markers: A Prospective, Observational, Multicenter Study
- ClinicalTrials.gov ID
- NCT07087041
- Acronym / sponsor ID
- LEAD-2 / 2025-P2-244-01
- Conditions
- Decompensated Cirrhosis, Hepatitis B Virus (HBV) Infection, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Alcohol-Related Liver Disease, Portal Hypertension, Recompensation
- Keywords
- Recompensation, Decompensated Cirrhosis, Spleen Stiffness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 735 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, observational, multicenter study designed to follow adults with decompensated cirrhosis who are receiving effective treatment for the underlying cause of their liver disease, such as antiviral therapy, alcohol abstinence, or metabolic management. The study is aiming to understand how these patients recover after treatment; Identify how often they achieve recompensation and stable recommendation; Develop a non-invasive model using spleen stiffness and other markers to predict who is more likely to improve.
Participants will be grouped based on whether they have had decompensation within the past 12 months. Researchers will regularly collect clinical data, spleen stiffness measurements, and lab tests, to develop and validate a model that predicts recompensation and stable recompensation. The study will also assess the cumulative incidence of clinical events (e.g., further decompensation, hepatocellular carcinoma, liver transplantation, and death) over a two-year follow-up period. Predictive accuracy, model calibration, and discrimination will be evaluated using standard statistical methods, including competing risk models and AUROC analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recompensation group | – | –≥12 months since the last decompensated event |
| Non-recompensation group | – | –<12 months since the last decompensated event |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 to 75 years with decompensated cirrhosis who are receiving and maintaining effective treatment for the underlying cause of liver disease. The first decompensation event must be clinically significant ascites and/or variceal bleeding. Participants must have either experienced their first decompensation within the past 12 months or remained free from new decompensation events during the past 12 months.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation
Time frame: 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.
8 secondary outcomes
Discrimination, calibration, and stability of the prediction model
Time frame: 2 years
Predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation
Time frame: 2 years
Predictive accuracy of liver stiffness in identifying recompensation and stable recompensation
Time frame: 2 years
Predictive accuracy of platelets in identifying recompensation and stable recompensation
Time frame: 2 years
Cumulative incidence of recompensation by etiology
Time frame: 2 years
Cumulative incidence of stable recompensation by etiology
Time frame: 2 years
Cumulative incidence of further decompensation by etiology
Time frame: 2 years
Cumulative incidence of liver-related composite endpoints by etiology
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes. The individual participant data to be shared include de-identified demographic information, clinical characteristics, laboratory test results (including spleen stiffness, liver stiffness, platelet counts, and other routine blood tests), treatment details, and clinical outcomes related to recompensation and stable recompensation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong You, Prof. principal investigator
Beijing Friendship Hospital
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompensated Cirrhosis and Hepatitis B Virus (HBV) Infection, run by Beijing Friendship Hospital at 28 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingqiong Wang, Dr (86-010-63138665, 13031136358@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.