NCT00502086已完成3 期
Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection. A Randomized, Controlled and Double Blind Study.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The mortality secondary to liver failure at 96 weeks.
研究概览
简要总结
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison with placebo, during 96 weeks of treatment.
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
- Double (Participant, Investigator)
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
- •Histological or clinical diagnosis of cirrhosis.
- •HCV infection confirmed on a positive test for anti-HCV antibody and HCV RNA detectable in serum by Polymerase Chain Reaction.
- •Patients who were non-responders to previous treatment with pegylated interferon and ribavirin or naïve patients with decompensated cirrhosis (Child-Pugh score ≥ 7) who had contraindicated the antiviral treatment.
- •Presence of compensated or decompensated (Stage A, B or C according to the Child-Pugh Classification).
- •Absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.
排除标准
- •Age less than 18 or greater than 70 years.
- •Presence of uncontrollable clinical or biochemical complications related to severe liver failure (hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, serum bilirubin level greater than 5 mg/dL, international normalized ratio greater than 2.5).
- •Active alcoholism.
- •Serum creatinine greater than 2 mg/dL.
- •Hepatocellular carcinoma.
- •Refusal to participate in the study.
- •Concomitant disease with reduced life expectancy.
- •Severe psychiatric conditions.
- •Co-infection with hepatitis A or B or HIV.
- •Drug dependence.
- •Pregnancy.
结局指标
主要结局
The mortality secondary to liver failure at 96 weeks.
时间窗: 96 weeks
次要结局
- The complication rates during the treatment. The hepatitis-related quality of live during the treatment. Clinical Activity Index during the treatment. The hepatocellular carcinoma incidence during the treatment.(96 weeks)
研究者
研究点 (2)
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