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Active Not Recruiting
NCT07739901
Korean Real-world Study on MASLD/MASH Outcomes.
Conditions: MASLD/MASH
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 10000
Sponsor: Novo Nordisk A/S
Location: Novo Nordisk Investigational Site Seoul
Summary
This retrospective multicentre cohort study will use existing medical records from adults with Metabolic Dysfunction-Associated Steatotic Liver Disease or Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH) who underwent two Vibration-Controlled Transient Elastography-Liver Stiffness Measurement (VCTE-LSM) (FibroScan) assessments during routine clinical care. The study will evaluate whether changes in fibrosis risk tier between the two assessments are associated with future major liver-related outcomes and all-cause mortality. The duration of study will be 5 months.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older at the cohort entry date.
* At least two VCTE examinations during the data period, with the interval between the first and second VCTE between 1 year and 5 years (both inclusive).
* Diagnosis of MASLD, defined as the coexistence of hepatic steatosis confirmed by histology, imaging, or VCTE-Controlled Attenuation Parameter (CAP) more than or equal to (≥) 248 decibels per meter (dB/m), and at least one cardiometabolic criterion, in accordance with the Multi-society MASLD nomenclature consensus.
Exclusion Criteria:
* Prior history of hepatocellular carcinoma at any time before index date.
* Prior history of decompensated cirrhosis (any of: bleeding oesophageal varices, ascites, hepatic encephalopathy, hepatorenal syndrome) at any time before index date.
* Prior history of liver resection or transplantation at any time before index date.
* Prior diagnosis of any extrahepatic malignancy at any time before index date.
* Occurrence of any MALO component (HCC, complication of liver cirrhosis, liver transplantation, or death) within 6 months after the index date.
* Antiviral treatment for hepatitis B or hepatitis C virus initiated more than 3 months before the index date and ongoing through the index date.
* Total post-index follow-up duration of less than 6 months.
* Insufficient medical record data preventing operationalisation of key study variables.
Source: ClinicalTrials.gov (NCT07739901). StuddyBuddy aggregates publicly available trial information.