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Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis

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Capital Medical University

Status

Enrolling

Conditions

Chronic Hepatitis b
Non-Alcoholic Fatty Liver Disease

Study type

Observational

Funder types

Other

Identifiers

NCT05786963
YYYXYJ-2022-095

Details and patient eligibility

About

Totals of 400 chronic hepatitis B or non-alcoholic fatty liver disease (NAFLD) patients with or without cirrhosis will be enrolled. Patients' clinical characteristics, including alanine aminotransferase, aspartic aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, triglyceride and total cholesterol, hepatitis B surface antigen, steatosis, and liver stiffness measurement will be collected. The consistence of liver fibrosis and steatosis assessment between Hepatus and FibroScan will be evaluated in this study.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease;
  • Age above 18 years;
  • Signature of informed consent.

Exclusion criteria

  • Patients with HCV and/or other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic liver disease or other chronic liver diseases;
  • Patients with decompensated cirrhosis;
  • Patients with serum total bilirubin level higher than 51 umol/L;
  • Patients with liver malignant lesion, hemangiomas, giant liver cysts and other liver lesions;
  • Patients with HIV infections;
  • Patients after liver transplantation or TIPS;
  • Pregnant women;
  • Patients with Budd-Chiari syndrome, chronic congestive heart failure, constrictive pericarditis or other liver congestion lesions.

Trial contacts and locations

1

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Central trial contact

Shuyan Chen, Doctor; Hong You, Doctor

Data sourced from clinicaltrials.gov

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