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

Phase 4

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: lamivudine; Drug: Telbivudine; Drug: Enticavir; Drug: Adefovir Dipivoxil Tablets

• Registration Number: NCT00810524
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Status Verified: 2008-10
• Study First Submitted: 2008-12-01
• Study First Submitted QC: 2008-12-17
• Last Update Submitted: 2008-12-17
• Study First Posted: 2008-12-18
• Last Update Posted: 2008-12-18
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Telbivudine	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).
A	Enticavir	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).
A	Adefovir Dipivoxil Tablets	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).
B	Enticavir	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).
B	Adefovir Dipivoxil Tablets	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).
C	lamivudine	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).
C	Telbivudine	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).
C	Enticavir	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).
C	Adefovir Dipivoxil Tablets	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).
D	lamivudine	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).
D	Enticavir	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).
D	Adefovir Dipivoxil Tablets	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).
A	lamivudine	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).
B	lamivudine	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).
B	Telbivudine	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).
D	Telbivudine	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).

Primary Outcome Measures

Name	Time	Method
incidence rate of hepatic carcinoma	10 years after treatment
incidence rate of liver cirrhosis	10 years after treatment
incidence rate of fulminant hepatitis	10 years after treatment

Trial Locations

Locations (1)

The Third Affiliated Hospital Of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China