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A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database

A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06741111
Acronym
IMPACT MASH
Enrollment
1233970
Registered
2024-12-18
Start date
2025-01-21
Completion date
2025-05-27
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)

Brief summary

The primary objective of this study is to estimate the proportion of people with low/intermediate/high risk of advanced fibrosis in at risk Chinese population based on the European Association for the Study of the Liver (EASL) 2024 care pathway

Interventions

OTHERNo treatment given

No treatment given

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

For All and Study population: 1. Male or female, age above or equal to 18 years on health-check-up visit day 2. No missing value on sex For EASL at risk population 1. Must be part of study population. 2. People with T2D or \[obesity+above or equal to 1 cardiometabolic risk factor(s)\] or elevated liver enzymes For EASL not at-risk population 1\. Must be part of study population. For EASL-SAFE 1. Must be part of EASL at risk population For AGA at risk population 1. Must be part of study population. 2. People with 2 or more metabolic risk factors (EASL-MASLD criteria) or T2D or steatosis on any imaging modality or with elevated aminotransferases For CSH MAFLD population 1. Must be part of study population. 2. Liver steatosis on abdominal ultrasound 3. With at least one component of Metabolic syndrome (MetS \[CSH\])

Exclusion criteria

1. Individuals originating from centers with fewer than 100 participants 2. Missing value of liver stiffness measurement (LSM) 3. Had an interquartile range/median ratio above or equal to 30% of the measurement of LSM 4. Missing value on either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or platelet count (PLT) 5. Missing value on FPG, TG, HDLc or BP (to define the presence of metabolic risk factors) 6. Missing value on abdominal ultrasound For EASL not at-risk population 1. People with T2D or \[obesity+above or equal to 1 cardiometabolic risk factor(s)\] or elevated liver enzymes For EASL-SAFE/NFS 1\. Missing value on globulin

Design outcomes

Primary

MeasureTime frameDescription
The proportion of people with low/intermediate/high risk of advanced fibrosis in EASL at risk population based on EASL 2024 care pathway.January 1st, 2023, to December 31st, 2023Number and proportion of people in respective risk population

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026