NCT05766449

Brief Summary

Chronic hepatitis B (CHB) affects an estimated 292 million people, and causes approximately 800,000 people deaths per year from liver-related complications including cirrhosis and hepatocellular carcinoma, remaining a major global public health issue.Meanwhile, with the improvement of living standards and changes in lifestyle and dietary habits, non-alcoholic fatty liver disease (NAFLD) has become another important cause of liver cirrhosis and HCC.HBV combined with NAFLD inevitably develops into continuous or intermittent liver inflammation and fibrosis, which greatly increases the risk of cirrhosis, liver cancer and even end-stage liver disease. We aimed to investigate the risk factors and establish diagnostic models for hepatic inflammation, fibrosis in patients with CHB associated NAFLD. In addition, to find risk factors for liver cirrhosis, liver cancer or liver failure in patients with CHB-related NAFLD.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jun 2022

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jun 2022May 2027

Study Start

First participant enrolled

June 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

4.8 years

First QC Date

February 21, 2023

Last Update Submit

March 2, 2023

Conditions

Chronic Hepatitis bNon-alcoholic Fatty Liver Disease

Keywords

chronic hepatitis bnonalcoholic fatty liver diabetesinflammationfibrosisprognosis

Outcome Measures

Primary Outcomes (4)

  • Risk factors for hepatic inflammation or fibrosis in chronic hepatitis B patients with non-alcoholic fatty liver disease

    Risk factors for hepatic inflammation or fibrosis in patients with chronic hepatitis B and non-alcoholic fatty liver disease at baseline

    0 year

  • Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure

    Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure during 1-year follow-up

    1 year

  • Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure

    Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure during 3-year follow-up

    3 years

  • Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure

    Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure during 5-year follow-up

    5 years

Secondary Outcomes (6)

  • Establishment a diagnostic model for hepatic inflammation in chronic hepatitis B patients with non-alcoholic fatty liver disease

    0 year

  • Establishment a diagnostic model for hepatic fibrosis in patients with chronic hepatitis B and non-alcoholic fatty liver disease

    0 year

  • Establishment predictive models for the progression of chronic hepatitis B patients with non-alcoholic fatty liver disease to cirrhosis, liver cancer or liver failure

    1 year

  • Establishment predictive models for the progression of chronic hepatitis B patients with non-alcoholic fatty liver disease to cirrhosis, liver cancer or liver failure

    3 years

  • Establishment predictive models for the progression of chronic hepatitis B patients with non-alcoholic fatty liver disease to cirrhosis, liver cancer or liver failure

    5 years

  • +1 more secondary outcomes

Eligibility Criteria

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

chronic hepatitis B (CHB) patients concurrent with nonalcoholic fatty liver disease (NAFLD)

You may qualify if:

  • years or older 2. Positive hepatitis B surface antigen (HBsAg) for at least 6 months and without other viral co-infection at baseline 2.NAFLD diagnosed by imaging liver biopsy, and/or blood testing/predictive indices

You may not qualify if:

  • Other chronic liver diseases, such as alcoholic liver disease, other viral hepatitis, drug-induced liver injury;
  • HCC or other malignancies before liver biopsy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, China

RECRUITING

Related Publications (2)

  • Rui F, Xu L, Yeo YH, Xu Y, Ni W, Tan Y, Zheng Q, Tian X, Zeng QL, He Z, Qiu Y, Zhu C, Ding W, Wang J, Huang R, Xue Q, Wang X, Chen Y, Fan J, Fan Z, Ogawa E, Kwak MS, Qi X, Shi J, Wong VW, Wu C, Li J. Machine Learning-Based Models for Advanced Fibrosis and Cirrhosis Diagnosis in Chronic Hepatitis B Patients With Hepatic Steatosis. Clin Gastroenterol Hepatol. 2024 Nov;22(11):2250-2260.e12. doi: 10.1016/j.cgh.2024.06.014. Epub 2024 Jun 19.

    PMID: 38906440DERIVED

  • Rui F, Yeo YH, Xu L, Zheng Q, Xu X, Ni W, Tan Y, Zeng QL, He Z, Tian X, Xue Q, Qiu Y, Zhu C, Ding W, Wang J, Huang R, Xu Y, Chen Y, Fan J, Fan Z, Qi X, Huang DQ, Xie Q, Shi J, Wu C, Li J. Development of a machine learning-based model to predict hepatic inflammation in chronic hepatitis B patients with concurrent hepatic steatosis: a cohort study. EClinicalMedicine. 2024 Jan 16;68:102419. doi: 10.1016/j.eclinm.2023.102419. eCollection 2024 Feb.

    PMID: 38292041DERIVED

MeSH Terms

Conditions

Hepatitis B, ChronicNon-alcoholic Fatty Liver DiseaseInflammationFibrosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jie Li, M.D., Ph.D

CONTACT

15863787910lijier@sina.com

Fajuan Rui

CONTACT

18353185039ruifajuan@163.com

Study Design

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

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 13, 2023

Study Start

June 1, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

CN(1)