Hepatitis B, Chronic
Conditions
Keywords
HBV, metabolic diseases
Brief summary
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
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
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of NAs therapy | 2 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of liver fibrosis and cirrhosis | 2 year | 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) |
Countries
China