Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis

NCT ID: NCT05786963

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-29

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis b Non-Alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hong You

Vice President of Beijing Friendship Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong You, doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Yameng Sun

Beijing, Select A State Or Province, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong You, Doctor

Role: CONTACT

86-010-63139019

Shuyan Chen, Doctor

Role: CONTACT

86-010-63138656

Facility Contacts

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Shuyan Chen, Doctor

Role: primary

8610-63138656

Yameng Sun, Doctor

Role: backup

8610-63138656

Other Identifiers

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YYYXYJ-2022-095

Identifier Type: -

Identifier Source: org_study_id

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