Clinical trial NCT05766449: Risk Factors for Hepatic Inflammation, Fibrosis and Prognosis in Patients With CHB and NAFLD
Official title: Risk Factors for Hepatic Inflammation, Fibrosis and Prognosis in Patients With Chronic Hepatitis B Combined With Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis b
Non-alcoholic Fatty Liver Disease
Keywords: chronic hepatitis b
nonalcoholic fatty liver diabetes
inflammation
fibrosis
prognosis
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic hepatitis B (CHB) patients concurrent with nonalcoholic fatty liver disease (NAFLD)

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Risk factors for hepatic inflammation or fibrosis in chronic hepatitis B patients with non-alcoholic fatty liver disease
timeFrame: 0 year
measure: Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure
timeFrame: 1 year
measure: Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure
timeFrame: 3 years
measure: Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure
timeFrame: 5 years
Secondary outcomes:
measure: Establishment a diagnostic model for hepatic inflammation in chronic hepatitis B patients with non-alcoholic fatty liver disease
timeFrame: 0 year
measure: Establishment a diagnostic model for hepatic fibrosis in patients with chronic hepatitis B and non-alcoholic fatty liver disease
timeFrame: 0 year
measure: Establishment predictive models for the progression of chronic hepatitis B patients with non-alcoholic fatty liver disease to cirrhosis, liver cancer or liver failure
timeFrame: 1 year
measure: Establishment predictive models for the progression of chronic hepatitis B patients with non-alcoholic fatty liver disease to cirrhosis, liver cancer or liver failure
timeFrame: 3 years
measure: Establishment predictive models for the progression of chronic hepatitis B patients with non-alcoholic fatty liver disease to cirrhosis, liver cancer or liver failure
timeFrame: 5 years
measure: Incidence of cirrhosis, cancer and liver failure in patients with chronic hepatitis B and non-alcoholic fatty liver disease
timeFrame: 5 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
Study officials:
References: