Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Serum HBV DNA
研究概览
简要总结
Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.
详细描述
Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver cirrhosis with CHB
- •without history of antiviral therapy or discontinued antiviral therapy for more than 6 months
- •for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative
- •for patients with uncompensated liver cirrhosis:HBV DNA positive
排除标准
- •coinfection with HCV,HDV and HIV
- •AFP≥100mg/L or HCC diagnosed by iconography
- •with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases
研究组 & 干预措施
telbivudine
干预措施: telbivudine (Drug)
结局指标
主要结局
Serum HBV DNA
时间窗: 48 weeks
serum HBV DNA negativity and decline from baseline at week 48
次要结局
- Serum HBeAg(48 weeks)
- Child-pugh score(48 weeks)