MAFLDMAFLDNCT07777198
Liver Stiffness Changes by iLivTouch to Predict Liver-Related Events in MAFLD
An observational study of MAFLD, run by Beijing Friendship Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MAFLD
- How many people
- 2,303 participants
- Where
- No sites listed yet
- Study dates
- 17 Nov 2026to 30 Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Aged ≥18 years, both male and female.
- Clinically diagnosed with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) and progressed to compensated advanced chronic liver disease (cACLD) according to the 2024 Chinese Guidelines for the Management of Metabolic-Associated (Non-Alcoholic) Fatty Liver Disease. cACLD is defined as baseline liver stiffness measurement (LSM1) ≥10 kPa based on the Baveno-VII consensus.
- At least two valid LSM measurements during follow-up, with an interval of no less than 12 months between the two measurements.
Who cannot join
- Co-existing other chronic liver diseases, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, etc.
- Weekly alcohol intake ≥210 g for men or ≥140 g for women.
- Occurrence of liver-related endpoint events within 6 months before or after obtaining the LSMC value.
- Hepatectomy or liver transplantation performed within 6 months before or after obtaining the LSMC value.
- Malignant neoplasm diagnosed within 6 months before or after obtaining the LSMC value.
- Presence of vascular liver disease, cystic fibrosis-related liver disease, sarcoidosis, polycystic liver disease, congenital or rare inherited liver disease, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure complicated by hepatic venous congestion.
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- History of transjugular intrahepatic portosystemic shunt (TIPS).
- Acute hepatitis (alanine aminotransferase >5-fold upper limit of normal) or acute-on-chronic liver failure (ACLF) occurring at the time of LSM1 or LSMC measurement.
- Missing value of either LSM1 or LSMC.
- Any other conditions judged by investigators to be inappropriate for study participation.
About this study
Official title: Exploring the Risk Prediction of Liver-Related Events in Metabolic-Associated Fatty Liver Disease Based on Changes in Liver Stiffness Values Measured by iLivTouch
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.
- Conditions
- MAFLD
- Keywords
- Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD), Compensated Advanced Chronic Liver Disease (cACLD), liver stiffness measurement, liver-related events
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline LSM1 until documented cACLD resolution, loss to follow-up, or study end, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start17 Nov 2026 (estimated)
- Primary completion16 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MAFLDStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,303 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, First Hospital of China Medical University, Panzhihua Central 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
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777198
- Sponsor's protocol ID
- 2026-P2-406-01
- Acronym
- MAFLD
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Risk Prediction of Liver-Related Events in Metabolic-Associated Fatty Liver Disease Based on Changes in Liver Stiffness Values Measured by iLivTouch
- ClinicalTrials.gov ID
- NCT07777198
- Acronym / sponsor ID
- MAFLD / 2026-P2-406-01
- Conditions
- MAFLD
- Keywords
- Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD), Compensated Advanced Chronic Liver Disease (cACLD), liver stiffness measurement, liver-related events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,303 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, First Hospital of China Medical University, Panzhihua Central 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
- Study start
- 17 Nov 2026 (estimated)
- Primary completion
- 16 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 20 Aug 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Aged ≥18 years, both male and female.
- Clinically diagnosed with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) and progressed to compensated advanced chronic liver disease (cACLD) according to the 2024 Chinese Guidelines for the Management of Metabolic-Associated (Non-Alcoholic) Fatty Liver Disease. cACLD is defined as baseline liver stiffness measurement (LSM1) ≥10 kPa based on the Baveno-VII consensus.
- At least two valid LSM measurements during follow-up, with an interval of no less than 12 months between the two measurements.
Key exclusion criteria (10 listed)
- Co-existing other chronic liver diseases, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, etc.
- Weekly alcohol intake ≥210 g for men or ≥140 g for women.
- Occurrence of liver-related endpoint events within 6 months before or after obtaining the LSMC value.
- Hepatectomy or liver transplantation performed within 6 months before or after obtaining the LSMC value.
- Malignant neoplasm diagnosed within 6 months before or after obtaining the LSMC value.
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
Predictive performance of liver stiffness measurements (LSM1, LSMC and their dynamic changes) for liver-related events (LREs) and all-cause mortality
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
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.
4 secondary outcomes
Difference in risk of LREs between patients with significant LSMC decline versus non-significant LSMC decline within resolved cACLD subgroup
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
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
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
Time frame: From baseline LSM1 until documented cACLD resolution, loss to follow-up, or study end, up to 10 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 30 Oct 2026.
- Individual participant dataSharing planned: No
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MASLD
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of MAFLD, run by Beijing Friendship Hospital.
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 3 inclusion and 10 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of liver stiffness measurements (LSM1, LSMC and their dynamic changes) for liver-related events (LREs) and all-cause mortality (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). 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 30 Oct 2026.