An observational study in MAFLD, sponsored by Beijing Friendship Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Beijing Friendship Hospital · Observational
The First Affiliated Hospital of Soochow University · Wuxi Fifth People's Hospital · Jiangsu Taizhou People's Hospital · Suzhou Fifth People's Hospital · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Shanghai General Hospital, China · The First Affiliated Hospital of Zhengzhou University · Fifth Affiliated Hospital of Guangzhou Medical University · Southern Medical University Shunde Hospital · Yangjiang City Public Health Hospital · Gui Gang City People's Hospital · First Affiliated Hospital of Chongqing Medical University · The Second Affiliated Hospital of Baotou Hospital in Inner Mongolia · Shengjing Hospital · Tianjin Third Central Hospital · Jiamusi Infectious Disease Hospital
This is an observational study (multicenter retrospective real-world cohort study). The purpose of this study is to assess the predictive performance of liver stiffness measurement (LSM, including baseline LSM1, current LSMC and their dynamic changes) acquired by domestic iLivTouch device for liver-related events (LREs) and all-cause mortality among MAFLD patients with compensated advanced chronic liver disease (cACLD), and to explore the prognostic value of dynamic LSM changes. The study population consists of adult patients aged ≥18 years of either sex, clinically diagnosed with MAFLD-related cACLD (defined as baseline LSM1 ≥10 kPa per Baveno-VII consensus), with at least two LSM measurements separated by ≥12-month follow-up interval, and without other confounding chronic liver diseases, excessive alcohol intake or predefined exclusion comorbidities. This study aims to answer several major questions: whether dynamic LSM parameters measured by iLivTouch can predict LREs and all-cause mortality in MAFLD-cACLD patients; whether risk of LREs differs between patients with significant LSMC decline and those without such decline in the resolved cACLD subgroup; whether liver-related mortality differs between resolved and persistent cACLD patients; and whether pharmacological interventions influence LRE risk and cACLD resolution.
Beijing Friendship Hospital is the lead sponsor of 217 studies on the registry; 94 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Multicenter retrospective real-world cohort of adult patients (≥18 years) with MAFLD-related compensated advanced chronic liver disease (cACLD, LSM1 ≥10 kPa per Baveno-VII consensus). Participants must have at least two LSM measurements ≥12 months apart. Patients with competing chronic liver diseases, excessive alcohol consumption, malignancies, TIPS history, acute liver injury and other predefined conditions are excluded from this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Predictive performance of liver stiffness measurements (LSM1, LSMC and their dynamic changes) for liver-related events (LREs) and all-cause mortality
Area under the receiver operating characteristic curve (AUC) will be used to evaluate the predictive performance of baseline liver stiffness (LSM1), current liver stiffness (LSMC), and their dynamic changes for liver-related events (LREs) and all-cause mortality in patients with MAFLD-related cACLD.
Time frame: From the time of baseline LSM1 measurement until occurrence of LREs, death, loss to follow-up, or end-of-study cutoff, assessed up to 10 years
Difference in risk of LREs between patients with significant LSMC decline versus non-significant LSMC decline within resolved cACLD subgroup
Cox proportional-hazards model will be applied to compare the risk of liver-related events (LREs) between resolved cACLD patients with significant LSMC decline (≥20 % LSM reduction or LSMC \< 10 kPa) and those without significant LSMC decline.
Time frame: From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years
Difference in liver-related mortality risk between resolved cACLD patients and persistent cACLD patients
Competing-risk regression model will be used to compare liver-related mortality risk between patients with resolved cACLD and patients with persistent cACLD.
Time frame: From baseline LSM1 until liver-related death, death from other causes, loss to follow-up, or study end, up to 10 years
Association between pharmacological interventions and risk of LREs among cACLD patients
Cox proportional-hazards model will be used to explore whether different pharmacological interventions are associated with significant differences in the risk of liver-related events (LREs) in cACLD patients.
Time frame: From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years
Association between pharmacological interventions and cACLD resolution
Logistic regression model will be used to explore whether different pharmacological interventions are associated with significant differences in the probability of cACLD resolution.
Time frame: From baseline LSM1 until documented cACLD resolution, loss to follow-up, or study end, up to 10 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2027, 10 months later.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
The First Affiliated Hospital of Soochow University · Wuxi Fifth People's Hospital · Jiangsu Taizhou People's Hospital · Suzhou Fifth People's Hospital · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Shanghai General Hospital, China · The First Affiliated Hospital of Zhengzhou University · Fifth Affiliated Hospital of Guangzhou Medical University · Southern Medical University Shunde Hospital · Yangjiang City Public Health Hospital · Gui Gang City People's Hospital · First Affiliated Hospital of Chongqing Medical University · The Second Affiliated Hospital of Baotou Hospital in Inner Mongolia · Shengjing Hospital · Tianjin Third Central Hospital · Jiamusi Infectious Disease Hospital
The First Affiliated Hospital of Soochow University · Wuxi Fifth People's Hospital · Jiangsu Taizhou People's Hospital · Suzhou Fifth People's Hospital · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Shanghai General Hospital, China · The First Affiliated Hospital of Zhengzhou University · Fifth Affiliated Hospital of Guangzhou Medical University · Southern Medical University Shunde Hospital · Yangjiang City Public Health Hospital · Gui Gang City People's Hospital · First Affiliated Hospital of Chongqing Medical University · The Second Affiliated Hospital of Baotou Hospital in Inner Mongolia · Shengjing Hospital · Tianjin Third Central Hospital · Jiamusi Infectious Disease Hospital
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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