NCT06779058

Brief Summary

How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). We plan to investigate the ability of magnetic resonance elastography (MRE) to grade fibrosis in chronic hepatitis B and apply to clinical longitudinal follow-up.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

January 10, 2025

Last Update Submit

February 26, 2026

Conditions

Chronic Hepatitis BLiver Fibrosis

Keywords

Magnetic resonance elastographyLiver stiffnessAntiviral therapy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the features of MRE for grading fibrosis in chronic hepatitis B.

    WIth liver biopsy as reference standand, the diagnostic perforemace (accuracy) for fibrosis of MRE was assessed.

    6 months

Secondary Outcomes (2)

  • The efficacy of grading liver fibrosis in CHB patients evaluated by MRE superior to TE and serological indicators (APRI, FIB-4).

    6 months

  • The excellent ability of MRE as a non-invasive biomarker for longitudinal monitoring in CHB patients.

    12 months

Study Arms (2)

Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B

Patients aged ≥ 18 who have been diagnosed with chronic hepatitis B from Jan 2010 to Oct 2024

Device: MREDevice: Liver biopsy

Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B

Patients aged ≥ 18 who have been diagnosed with chronic hepatitis B, both treated and untreated from Aug 2022

Device: MREDevice: Liver biopsy

Interventions

MREDEVICE

All imaging studies were performed by using a 1.5T/3.0-T MRI system

Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis BRetrospective cohort of patients confirmed diagnosed with chronic hepatitis B
Liver biopsyDEVICE

Liver biopsy are performed by well-trained pathologists in accordance with standard operating procedures.

Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis BRetrospective cohort of patients confirmed diagnosed with chronic hepatitis B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Organize paticipating units to collect standard-of-care data including radiological and clinical data. Patients diagnosed with CHB who received liver biopsy and MRE should be enrolled.

You may qualify if:

  • Age ≥ 18 years old
  • Confirmed CHB (laboratory, imaging and clinical tests)
  • MRE within 6 months before and after liver biopsy
  • Treatment-naïve
  • Child-Pugh Grade A (\<7 points)
  • Written informed consent in prospective follow-up cohort

You may not qualify if:

  • Patients with liver malignant tumor
  • Chronic hepatitis due to other causes (such as alcoholic hepatitis)
  • CHB combined with hepatitis C, hepatitis D, or HIV
  • Patients with biliary tract diseases
  • Contraindications of MRE examination, MRE failure
  • Poor pathological effect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 210000, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, ChronicLiver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yu Shi

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiyang Wang

CONTACT

+86 1529101490715291014907@163.com

Yu Shi

CONTACT

+86 189 4025 998018940259980@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of department of radology

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 16, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

CN(1)