Non-Invasive Model for Fibrosis Regression in HBV Patients | NCT06874127

Studies
Non-Invasive Model for Fibrosis Regression in HBV Patients

NCT06874127

Sponsor

Beijing Friendship Hospital

Status

Recruiting

Last Update Posted

Mar 13, 2025Actual

Enrollment

1,100Estimated

Phase

Not provided

Conditions

Chronic Hepatitis B Virus (HBV) Infection
Liver Fibrosis

Interventions

Nucleos(t)ide Analogs (NA)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Z221100007422115	Other Grant/Funding Number	Beijing Municipal Science & Technology Commission

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Feb 1, 2026Estimated

Completion Date

May 1, 2026Estimated

First Submitted Date

Feb 26, 2025

First Submission Date that Met QC Criteria

Mar 11, 2025

First Posted Date

Mar 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2025

Last Update Posted Date

Mar 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Retrospective cohort-derivation cohort			Drug: Nucleos(t)ide Analogs (NA)
Retrospective cohort-validation cohort			Drug: Nucleos(t)ide Analogs (NA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nucleos(t)ide Analogs (NA)	Drug	all patients received NAs	Retrospective cohort-derivation cohort Retrospective cohort-validation cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of HBV-related clinical endpoint events	clinical endpoint event includes: liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death	7 years
Percentage of HBV-induced liver fibrosis regression

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Yameng Sun	Contact	0086-13810643902		sunyamenggo@163.com

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friendship Hospital	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic
D006509	Hepatitis B
D007239	Infections
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections

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