Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy

Study Overview
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Brief Summary
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Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Detailed Description
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Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Official Title
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Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Nucleos(t)ide Analogues


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up. Patients comply with the requirements of the trail voluntarily Written informed consent Exclusion Criteria: Pregnant woman or patient with severe disease Patients with poor adherence to the study Patients not suitable for the study evaluated by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

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 |
| --- | --- |
| Anti-viral therapy group<br>Subjects who have completed the 3 years research Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis | Drug: Nucleos(t)ide Analogues<br>* Entecavir 0.5mg daily, Lamivudine100mg qd daily, Adefovir Dipivoxil 10mg daily, telbivudine 600mg qd daily, their combination therapy, tenofovir 300mg qd daily.<br>* Other names: Baraclude , et al;|
| Non anti-viral therapy group<br>History study from literature | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death | Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy,Gastrointestinal hemorrhage)，and/or hepatocellular carcinoma， and/or liver related death after 10 years of antiviral treatment | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV-DNA undetectable rate | HBV-DNA undetectable rate after 10 years of antiviral treatment | 10 years | 
| Decrease of transient elastography | Decrease of transient elastography after 10 years of antiviral treatment | 10 years | 
| HBeAg seroconversion rate | HBeAg seroconversion rate after 10 years of antiviral treatment | 10 years | 
| HBsAg seroconversion rate | HBsAg seroconversion rate after 10 years of antiviral treatment | 10 years | 
| Decrease of Child-Pugh score | Decrease of Child-Pugh score after 10 years of antiviral treatment | 10 years | 
| Decrease of MELD score | Decrease of MELD score after 10 years of antiviral treatment | 10 years | 
| Improvement of life Quality assessed by SF-36 | Improvement of life Quality assessed by SF-36 after 10 years of antiviral treatment | 10 years | 
| Improvement of life Quality assessed by EQ-5D | Improvement of life Quality assessed by EQ-5D after 10 years of antiviral treatment | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cirrhosis