Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 606
- 试验地点
- 21
- 主要终点
- Decompensated rate of Liver Cirrhosis after 2 years treatment
研究概览
简要总结
Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan;
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from age 18 to 65 years ;
- •Male or female;
- •Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions);
- •endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension
- •if no endoscopy,should meet two of the four Criterias:
- •Imaging (US, CT or MRI, et al) showing Surface nodularity: Echogenecity
- •Platelet (PLT) < 100×10 < 9 >/L , no other interpretation
- •Albumin (ALB) < 35.0 g/L, or International Standard Value (INR) > 1.3 (Prothrombin Time (PT) prolonged > 3s), or Cholinesterase (CHE) decrease
- •Liver stiffness measurement value > 12.4 kpa (ALT<5×ULN)
- •HBeAg-positive, HBVDNA > 2×10<3> IU/ml or with HBeAg-negative patients, HBVDNA > 2×10<2> IU/ml;
- •Agree to be followed up regularly;
- •Signature of written inform consent.
排除标准
- •Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
- •Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for medicine in this study;
- •Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases;
- •Patients with baseline AFP level higher than 100ng/ml and possible malignant lesion on image, or AFP level higher than 100ng/ml for more than three months;
- •Creatinine > 1.5×ULN;
- •Patients with other uncured malignant tumors;
- •Patients with severe diseases of heart, lung, kidney, brain, blood system or other organs;
- •Patients with any other reasons not suitable for the study.
研究组 & 干预措施
Entecavir Therapy
Entecavir, 0.5mg, qd, oral, for 2 years
干预措施: Entecavir (Drug)
Entecavir plus thymosin therapy
Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year
干预措施: Entecavir (Drug)
Entecavir plus thymosin therapy
Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year
干预措施: Thymosin-α (Drug)
结局指标
主要结局
Decompensated rate of Liver Cirrhosis after 2 years treatment
时间窗: 2 years
Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.
次要结局
- Quality of Life(1 and 2-year)
- Liver stiffness measurement(1 and 2-year)
- Child-Pugh and MELD scores(1 and 2-year)
- The HBV DNA undetectable rate(1 and 2-year)
研究者
Hong You
Vice-Director Liver Research Centre
Beijing Friendship Hospital