Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- incidence rate of hepatic carcinoma
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg positive for more than 6 months.
- •HBeAg positive.
- •HBV DNA over 10E5 copies/ml.
排除标准
- •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.
研究组 & 干预措施
A
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).
干预措施: lamivudine (Drug)
A
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).
干预措施: Telbivudine (Drug)
A
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).
干预措施: Enticavir (Drug)
A
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).
干预措施: Adefovir Dipivoxil Tablets (Drug)
B
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).
干预措施: lamivudine (Drug)
B
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).
干预措施: Telbivudine (Drug)
B
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).
干预措施: Enticavir (Drug)
B
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).
干预措施: Adefovir Dipivoxil Tablets (Drug)
C
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).
干预措施: lamivudine (Drug)
C
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).
干预措施: Telbivudine (Drug)
C
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).
干预措施: Enticavir (Drug)
C
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).
干预措施: Adefovir Dipivoxil Tablets (Drug)
D
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).
干预措施: lamivudine (Drug)
D
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).
干预措施: Telbivudine (Drug)
D
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).
干预措施: Enticavir (Drug)
D
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).
干预措施: Adefovir Dipivoxil Tablets (Drug)
结局指标
主要结局
incidence rate of hepatic carcinoma
时间窗: 10 years after treatment
incidence rate of liver cirrhosis
时间窗: 10 years after treatment
incidence rate of fulminant hepatitis
时间窗: 10 years after treatment
次要结局
未报告次要终点