A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

Study Overview
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Brief Summary
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HBV(hepatitis B virus) with metabolic comorbidities may accelerate liver disease progression and increase the risk of HCC(Hepatocellular Carcinoma)development. It is reported combination of metabolic diseases and CHB is associated with substantially increased rates of liver cirrhosis and secondary liver-related events compared to CHB alone. Consequently, hepatitis B patients with metabolic comorbidities warrant particular attention in disease surveillance and evaluation of treatment indications.

Detailed Description
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Primary objective: To evaluate the impact of metabolic disease on the progression of chronic hepatitis B To observe HBsAg/HBeAg/HBV DNA changes /HBsAg seroconversion To determine high rates of Liver Cirrhosis and Hepatocellular Carcinoma Group 1 : CHB with diabetes Group 2 : CHB with hyperlipemia Group 3 : CHB without metabolic diseases Study Duration (in months) 24 months

Official Title
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Disease Progression and Intervention of Chronic HepatitisB Based on Diabetes and Hyperlipidemia

Conditions
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Hepatitis B, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start) Patients on-treatment with NAs Exclusion Criteria: Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) <=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study. History of depression or uncontrolled psychiatric disorders Subjects protected by law or not in a position to give consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperlipidemia<br>HBsAg(+) patients TC>5.17mmol/L（200mg/dl）and（or）TG>2.3mmol/L（200mg/dl） | |
| diabetes<br>HBsAg(+) patients FPG>126 mg/dL(7.0 mmol/L)Fasting is defined as no caloric intake for at least 8 h. | |
| CHB without metabolic disease<br>HBsAg(+) patients without diabetes/ obesity/hyperlipidemia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of NAs therapy | We will follow up patients every six months and all patients with a history of hepatitis B will be tested for HBsAg(+) and HBD-DNA.The curative effect was evaluated by observing the changes of serological indexes. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of liver fibrosis and cirrhosis | We will follow up patients every six months and all patients() with a history of hepatitis B will be tested for FibroScan. The influence of metabolic diseases on the progression of hepatitis B was evaluated by comparing the changes of liver hardness between groups（Hyperlipidemia，Diabetes and CHB without metabolic disease） | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV, metabolic diseases