NCT06874127

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

February 26, 2025

Last Update Submit

March 11, 2025

Conditions

Chronic Hepatitis B Virus (HBV) InfectionLiver Fibrosis

Keywords

chronic hepatitis BLiver stiffness measurementsfibrosis regressionnon-invasive

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of non-invasive model for fibrosis regression

    Liver fibrosis regression was defined as decrease \>= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score

    5 years

Secondary Outcomes (5)

  • Incidence of HBV-related clinical endpoint events

    7 years

  • Percentage of HBV-induced liver fibrosis regression

    5 years

  • AUROC of non-invasive model for fibrosis regression

    5 years

  • Sensitivity of non-invasive model for fibrosis regression

    5 years

  • Specificity of non-invasive model for fibrosis regression

    5 years

Study Arms (2)

Retrospective cohort-derivation cohort

Drug: Nucleos(t)ide Analogs (NA)

Retrospective cohort-validation cohort

Drug: Nucleos(t)ide Analogs (NA)

Interventions

Nucleos(t)ide Analogs (NA)DRUG

all patients received NAs

Retrospective cohort-derivation cohortRetrospective cohort-validation cohort

Eligibility Criteria

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

CHB patients with liver biopsy performed at least 1 year after antiviral therapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis BInfectionsLiver Cirrhosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Central Study Contacts

Yameng Sun

CONTACT

0086-13810643902sunyamenggo@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 13, 2025

Study Start

February 1, 2024

Primary Completion

February 1, 2026

Study Completion

May 1, 2026

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)