Establishment and Application of a Non-Invasive Dynamic Model for Fibrosis Regression in Patients with Chronic Hepatitis B

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

A total of 1000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are retrospectively enrolled. All the patients received NAs treatment. Blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers were collected. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death were collected. Fibrosis regression prediction model based on dynamic changes in liver stiffness will be developed based on the retrospective cohort. An independent cohort of CHB patients with liver biopsy performed at least 1 year after antiviral therapy will be retrospectively enrolled for model validation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with liver biopsy performed at least 1 year after antiviral therapy;

• Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment.

Locations
Other Locations
China
Beijing Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Yameng Sun
sunyamenggo@163.com
0086-13810643902
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 1100
Treatments
Retrospective cohort-derivation cohort
Retrospective cohort-validation cohort
Sponsors
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov