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

Recruiting

• Conditions: Chronic Hepatitis b; Non-alcoholic Fatty Liver Disease

• Registration Number: NCT05766449
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-02-21
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13
• Primary Completion: 2027-03-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors for hepatic inflammation or fibrosis in chronic hepatitis B patients with non-alcoholic fatty liver disease	0 year	Risk factors for hepatic inflammation or fibrosis in patients with chronic hepatitis B and non-alcoholic fatty liver disease at baseline
Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure	5 years	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

Secondary Outcome Measures

Name	Time	Method
Establishment a diagnostic model for hepatic inflammation in chronic hepatitis B patients with non-alcoholic fatty liver disease	0 year	Establishment a diagnostic model of hepatic inflammation in chronic hepatitis B patients with non-alcoholic fatty liver disease using baseline data
Establishment a diagnostic model for hepatic fibrosis in patients with chronic hepatitis B and non-alcoholic fatty liver disease	0 year	Establishment a diagnostic model for hepatic fibrosis in chronic hepatitis B patients with non-alcoholic fatty liver disease using baseline data
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	Establishment predictive models for the progression of chronic hepatitis B patients with non-alcoholic fatty liver disease to cirrhosis, liver cancer or liver failure within 5 years
Incidence of cirrhosis, cancer and liver failure in patients with chronic hepatitis B and non-alcoholic fatty liver disease	5 years	Incidence of cirrhosis, cancer and liver failure in patients with chronic hepatitis B and non-alcoholic fatty liver disease for 1 year, 3 years and 5 years

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, China