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

Risk Factors for Hepatic Inflammation, Fibrosis and Prognosis in Patients With Chronic Hepatitis B Combined With Non-alcoholic Fatty Liver Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05766449
Enrollment
1000
Registered
2023-03-13
Start date
2022-06-01
Completion date
2027-05-01
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis b, Non-alcoholic Fatty Liver Disease

Keywords

chronic hepatitis b, nonalcoholic fatty liver diabetes, inflammation, fibrosis, prognosis

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.

Interventions

None listed

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Risk factors for hepatic inflammation or fibrosis in chronic hepatitis B patients with non-alcoholic fatty liver disease0 yearRisk 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 failure1 yearRisk 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

Secondary

MeasureTime frameDescription
Establishment a diagnostic model for hepatic inflammation in chronic hepatitis B patients with non-alcoholic fatty liver disease0 yearEstablishment 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 disease0 yearEstablishment 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 failure1 yearEstablishment predictive models for the progression of chronic hepatitis B patients with non-alcoholic fatty liver disease to cirrhosis, liver cancer or liver failure within one year
Incidence of cirrhosis, cancer and liver failure in patients with chronic hepatitis B and non-alcoholic fatty liver disease5 yearsIncidence 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

Countries

China

Contacts

Primary ContactJie Li, M.D., Ph.D
lijier@sina.com15863787910
Backup ContactFajuan Rui
ruifajuan@163.com18353185039

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026