Clinical Trial of Pentoxifylline in Patient With Cirrhosis
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
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.