A Prospective Open Label Control Study to Evaluate the Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- HBV DNA level and liver function
研究概览
简要总结
To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF were allocated into either a treatment group (ETV group, n=53) or a control group (n=55). The HBV DNA level, liver function and survival condition of the patients were observed for 48 weeks after enrollment. The factors possibly related to entecavir treatment efficacy were also identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACHBLF was diagnosed according to the criteria from the APASL in March 200815 and the program of Prevention and Cure for Viral Hepatitis and Liver Disease amended by the National Symposium on Viral Hepatitis and Liver Disease in September
- •age >18 years
- •HBV DNA > 3log10 copy/mL
排除标准
- •Pregnant or lactating women.
- •Diagnosed or suspected as hepatic carcinoma patients.
- •Cases with any serious disease besides CHB, including heart disease, immunologic disease, malignant tumor, etc.
- •Patients hypersensitive to nucleoside or nucleoside (acid) analogues or with a history nucleoside antiviral drug treatment.
- •A history of drug abuse or alcohol abuse.
- •Hepatic encephalopathy degree IV patients who were unable to take orally administered drugs.
- •A history of using immunomodulator including steroids
- •Conclusive evidence of other co infection s: anti-HAV-IgM positive, anti-HCV positive, anti-HEV positive, anti-HIV positive, autoimmunity liver diseases, Wilson disease, etc.
研究组 & 干预措施
Control group
The patients were prescribed the tradition comprehensive medical treatment without entecavir.
干预措施: Traditional comprehensive medical treatment (Drug)
ETV group
All the patients were prescribed the tradition comprehensive medical treatment with entecavir. Entecavir was supplied by the Sino-US Shanghai Squibb Pharmaceutical Co., Ltd. Patients took 0.5 mg entecavir following oral fasting one time per day.
干预措施: entecavir (Drug)
结局指标
主要结局
HBV DNA level and liver function
时间窗: 48 weeks
HBV DNA level,serum alanine transaminase (ALT), albumin (ALB), total bilirubin (TB), prothrombin time international normalize ratio （INR）， cholesterol (CHOL)
次要结局
- Symptoms,signs and mortality(48 weeks)