Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- liver function
研究概览
简要总结
The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.
详细描述
Chronic hepatitis B is one of the most widespread viral infections worldwide, potentially leading to liver cirrhosis and hepatocellular carcinoma. Previous studies demonstrated that patients with active viral replication, defined as the presence of detectable serum HBV-DNA or HBeAg, were at increased risk of developing progressive liver disease or death.The prognosis of decompensated cirrhosis resulting from chronic hepatitis B virus infection is poor. Anti-viral therapy in decompensated HBV-related cirrhosis has been recommended by the American Association for the Study of Liver Diseases. However, no high quality research on the effectiveness of anti-viral therapy in decompensated cirrhosis has been performed.
Entecavir is a new nucleotide analogue, which has been proved effective in suppressing viral replication and decreasing the necroinflammatory response, was recommended as a first-line medication in AASLD guideline. Our purpose was to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis. The main outcomes were liver function, HBV-DNA, disease progression, hepatocellular carcinoma, Child-Pugh score and the survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 16 years of age;
- •evidence of active viral replication was documented by a positive test for HBV-DNA in serum;
- •Liver cirrhosis was proven by ultrasound or CT;
- •Decompensated cirrhosis was evidenced by a Child-Pugh score ≥ 7;
- •patients had decompensation signs such as jaundice, ascites, variceal bleeding, hepatic encephalopathy
排除标准
- •evidence of hepatocellular carcinoma (suspicious foci on hepatic ultrasonography at screening or a rising serum level of alpha-fetoprotein)
- •a serum alanine aminotransferase level more than 10 times the upper limit of normal
- •coinfection with hepatitis C or D virus or human immunodeficiency virus
- •other types of cirrhosis
- •a history of anti-viral therapy
- •a total bilirubin level higher than 170 mmol/L
- •a history of malignant tumors
研究组 & 干预措施
A
Patients with decompensated HBV-related cirrhosis
干预措施: Entecavir (Drug)
结局指标
主要结局
liver function
时间窗: 1 year
HBV-DNA
时间窗: 1 year
次要结局
- disease progression(2 years)
- hepatocellular carcinoma(2 year)
- Child-Pugh score(2 year)
- motality(2 year)