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ClinicalTrials.gov ID

NCT00810524

Lead Sponsor

Sun Yat-sen UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

600Estimated

Last Update Posted

Dec 18, 2008Estimated

Start Date

Jan 2007

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2017Estimated

Official Title

Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.

Brief Summary

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.

• Hepatitis B, Chronic

• lamivudine
• Telbivudine
• Enticavir
• Adefovir Dipivoxil Tablets

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Sun Yat-sen UniversityOTHER

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