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Status unknownNCT05786963Updated Mar 28, 2023

Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis

An observational study in Chronic Hepatitis b and Non-Alcoholic Fatty Liver Disease, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Beijing Friendship Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Hepatitis b
  • Non-Alcoholic Fatty Liver Disease

Keywords

  • Chronic Hepatitis b
  • Non-alcoholic Fatty Liver Disease
  • Liver fibrosis/cirrhosis
  • Steatosis
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 400 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode.

    Consistency of liver stiffness and steatosis between Hepatus and FibroScan.

    Time frame: 1 to 3 years

Secondary outcomes

  1. Consistency of liver stiffness and steatosis results between Hepatus in continuous measurement mode and FibroScan in single detection mode through the respective localization methods.

    The localization method of Hepatus is the real-time two-dimensional image guiding system, which is manually location in FibroScan.

    Time frame: 1 to 3 years

  2. Consistency of liver stiffness and steatosis results between Hepatus and FibroScan in single detection mode.

    The localization methods include the respective localization methods in Hepatus and FibroScan, and manually locating.

    Time frame: 1 to 3 years

  3. Comparison of measurement performance in Hepatus under continuous detection mode and in FibroScan through single detection mode.

    Evaluation of measurement performance includes the rate of successful detection, time taken for validated detection, stability of liver stiffness measurement and controlled attenuation parameter.

    Time frame: 1 to 3 years

07

Study locations

1 of 1 sites recruiting
  • Yameng Sun
    Beijing, Select A State Or Province 100050, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05786963
Lead sponsor
Beijing Friendship Hospital
Responsible party
Hong You (Vice President of Beijing Friendship Hospital, Beijing Friendship Hospital) — Principal investigator
First posted
Mar 28, 2023
Start date
Dec 29, 2022
Primary completion
Dec 2023 (estimated)
Completion
Apr 2024 (estimated)
Last update
Mar 28, 2023

Study contacts

Hong You, Doctor
Contact
youhong30@sina.com
86-010-63139019
Shuyan Chen, Doctor
Contact
13552962655@163.com
86-010-63138656
Hong You, doctor
principal investigator · Beijing Friendship Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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