Risk Factors for Hepatic Inflammation, Fibrosis and Prognosis in Patients With CHB and NAFLD

NCT ID: NCT05766449

Last Updated: 2023-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2027-05-01

Brief Summary

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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.

Detailed Description

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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 of hepatic inflammation and fibrosis in CHB associated NAFLD patients using a multicenter study. In addition, to find risk factors for liver cirrhosis, liver cancer or liver failure in patients with CHB-related NAFLD.

Conditions

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Chronic Hepatitis b Non-alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1.18 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

Exclusion Criteria

1. Other chronic liver diseases, such as alcoholic liver disease, other viral hepatitis, drug-induced liver injury;
2. HCC or other malignancies before liver biopsy;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Jie Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nanjing Drum Tower Hospital

Nanjing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jie Li, M.D., Ph.D

Role: CONTACT

15863787910

Fajuan Rui

Role: CONTACT

18353185039

Facility Contacts

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Jie Li

Role: primary

15863787910

References

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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.

Reference Type DERIVED
PMID: 38906440 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38292041 (View on PubMed)

Other Identifiers

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CHB AND NAFLD

Identifier Type: -

Identifier Source: org_study_id

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