Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 入组人数
- 621
- 试验地点
- 8
- 主要终点
- Decompensation rate of liver cirrhosis
研究概览
简要总结
Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased, patients who had been chronically infected with HBV, especially those with liver cirrhosis cause great burden on public health care. In view of economic development level, drug availability and lack of independent health economics evidence, the investigators are still unable to give specific guidelines for HBV related compensated liver cirrhosis in China. Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through this prospective, open-label, multicenter and nonrandomized study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •aged 18-70 years
- •clinical diagnosis of compensated liver cirrhosis
- •liver biopsy showing cirrhosis
- •endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension
- •if no biopsy or endoscopy ，should meet two of the four:
- •Imaging(US, CT or MRI, et al) showing Surface nodularity： Echogenecity （spleen pachydiameter > 4.0cm or> 5 costal region）
- •PLT < 100×10 < 9 >/L，no other interpretation
- •ALB < 35.0 g/L, or INR > 1.3, or CHE < 5.0KU/L
- •Liver stiffness measurement value > 12.4 kpa
- •HBeAg(+)with HBVDNA > 10 < 3 > IU/mL or HBeAg(-) wtih HBVDNA > 102 IU/mL
排除标准
- •patient with decompensated liver cirrhosis:presence of ascites, variceal hemorrhage,hepatic encephalopathy
- •allergic to any ingredients of the drugs
- •patient complicated with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease.
- •AFP > 100ng/ml or Cr > 1.5×ULN
- •pregnant woman
- •patient with severe disease or other organ failure
- •patient with any tumors
- •patient with sever mental disease.
- •patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
研究组 & 干预措施
Group 1
Entecavir Therapy
干预措施: Entecavir (Drug)
Group 2
Lamivudine plus Adefovir Dipivoxil Therapy
干预措施: Lamivudine plus Adefovir Dipivoxil (Drug)
结局指标
主要结局
Decompensation rate of liver cirrhosis
时间窗: 3 years
presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC
次要结局
- liver elasticity(1, 2, and 3 years)
- child-pugh score(1,2 and 3 years)
- HBVDNA undetected(1,2 and 3 years)
- life quality score(1, 2 and 3 years)
- cost-effectiveness(1, 2 and 3 years)
研究者
Jia Ji-Dong
Director of Liver Research Center
Beijing Friendship Hospital