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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Enticavir; Drug: Adefovir Dipivoxil Tablets; Drug: Telbivudine; Drug: lamivudine

Study type: Interventional

Funder types: Other

Identifiers

NCT00810524

SunYat-senU 5010 Hepatitis B

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

A

Experimental group

Description:

120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment).

Treatment:

Drug: lamivudine

Drug: Telbivudine

Drug: Adefovir Dipivoxil Tablets

Drug: Enticavir

B

Active Comparator group

Description:

120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment).

Treatment:

Drug: lamivudine

Drug: Telbivudine

Drug: Adefovir Dipivoxil Tablets

Drug: Enticavir

C

Experimental group

Description:

180 subjects (have no family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment).

Treatment:

Drug: lamivudine

Drug: Telbivudine

Drug: Adefovir Dipivoxil Tablets

Drug: Enticavir

D

Active Comparator group

Description:

180 subjects (have no family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment).

Treatment:

Drug: lamivudine

Drug: Telbivudine

Drug: Adefovir Dipivoxil Tablets

Drug: Enticavir