Hepatitis B, Chronic Clinical Trial
Official title:
Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.
Influence of antiviral treatment to the long term prognosis of patients with chronic HBV infection. The aim of antiviral treatment for HBV is to reduce the long term severe complications. In this study, the investigators divided patients with chronic HBV infection into two groups, which start early antiviral treatment and conventional antiviral treatment respectively. All the patients will be followed for ten years. From this study, the investigators want to find out the optimal time for patients with chronic HBV infection to start antiviral treatment.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - HBsAg positive for more than 6 months. - HBeAg positive. - HBV DNA over 10E5 copies/ml. Exclusion Criteria: - Previous antiviral treatment for HBV. - Co infection of HIV, HCV, HEV, HAV, or HAV. - Evidence of hepatic carcinoma. - Evidence of autoimmune disease. - Evidence of thyroid disease. - History of mental sickness. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The Third Affiliated Hospital Of Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence rate of hepatic carcinoma | 10 years after treatment | Yes | |
Primary | incidence rate of liver cirrhosis | 10 years after treatment | Yes | |
Primary | incidence rate of fulminant hepatitis | 10 years after treatment | Yes |
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