NCT05786963

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 29, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

November 27, 2022

Last Update Submit

March 27, 2023

Conditions

Chronic Hepatitis bNon-Alcoholic Fatty Liver Disease

Keywords

Chronic Hepatitis bNon-alcoholic Fatty Liver DiseaseLiver fibrosis/cirrhosisSteatosis

Outcome Measures

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.

    1 to 3 years

Secondary Outcomes (3)

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

    1 to 3 years

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

    1 to 3 years

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

    1 to 3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yameng Sun

Beijing, Select A State Or Province, 100050, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, ChronicNon-alcoholic Fatty Liver DiseaseLiver CirrhosisFibrosisFatty Liver

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hong You, doctor

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong You, Doctor

CONTACT

86-010-63139019youhong30@sina.com

Shuyan Chen, Doctor

CONTACT

86-010-6313865613552962655@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Beijing Friendship Hospital

Study Record Dates

First Submitted

November 27, 2022

First Posted

March 28, 2023

Study Start

December 29, 2022

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

CN(1)