Clinical trial NCT06874127: Non-Invasive Model for Fibrosis Regression in HBV Patients
Official title: Establishment and Application of a Non-Invasive Dynamic Model for Fibrosis Regression in Patients with Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis B Virus (HBV) Infection
Liver Fibrosis
Keywords: chronic hepatitis B
Liver stiffness measurements
fibrosis regression
non-invasive
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CHB patients with liver biopsy performed at least 1 year after antiviral therapy

Brief 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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy;
* Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases;
* Patients with malignant lesion on liver image;
* Patients with other uncured malignant tumors;
* Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases;
* Pregnant or lactating women;
* Patients with any other reasons not suitable for the study.

Primary outcomes:
measure: Diagnostic accuracy of non-invasive model for fibrosis regression
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of HBV-related clinical endpoint events
timeFrame: 7 years
measure: Percentage of HBV-induced liver fibrosis regression
timeFrame: 5 years
measure: AUROC of non-invasive model for fibrosis regression
timeFrame: 5 years
measure: Sensitivity of non-invasive model for fibrosis regression
timeFrame: 5 years
measure: Specificity of non-invasive model for fibrosis regression
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
Study officials:
References: