Clinical Trial of Pentoxifylline Administration Versus Placebo on Survival in Patients With Cirrhosis and Severe Liver Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- survival rate at 2 months
研究概览
简要总结
In patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be responsible of severe complications and death. Thus, the prevention of cytokine production should prevent complications and mortality.
The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.
All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.
详细描述
The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.
All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patient of more than 18 years
- •child pugh C cirrhosis
排除标准
- •pregnant woman
- •Patient received anticoagulant
- •Patient treated for arterial hypertension
- •Patient with severe coronaropathy
- •Patient with hyper sensibility of pentoxifylline
- •Patient hospitalized for less 24 hours
- •Patient admitted for a treatment of hepatocellular-carcinoma or COLLANGIO- carcinoma
- •Patient with HIV
- •Patient who has been transplanted
- •Patient treated with immuno- suppressors
- •Patient who has already received pentoxifylline for 3 months before inclusion
- •Patient for whom the follow-up is considered impossible
研究组 & 干预措施
1
Patients with severe cirrhosis treated with Pentoxifylline
干预措施: pentoxifylline (Drug)
2
Patients with severe cirrhosis treated with a placebo
干预措施: PLACEBO (Drug)
结局指标
主要结局
survival rate at 2 months
时间窗: at 2 months
次要结局
- - survival rate at 6 months(at six months)
- - Number of patient with liver transplantation(during the study)
- - Complications : bacterial infection, renal insufficiency, hepatic encephalopathy, gastrointestinal bleeding(during the study)
- - Fibrotest and Acutest before, at 2 months and at 6 months(at 2 months and at 6 months)
- - TNF alpha and IL6 plasma concentration before, at 2 months and at 6 months as predictive factor of mortality(at 2 months and at 6 months as predictive factor of mortality)