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 pentoxifyllin – 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 pentoxifyllin will not be included. Patients receive either pentoxifyllin 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.

Condition	Intervention	Phase
Cirrhosis Liver Failure	Drug: pentoxifyllin	Phase III

Further Study Details: 

Primary Outcomes: survival rate at 2 months
Secondary Outcomes: - survival rate at 6 months; - Number of patient with liver transplantation; - Complications : bacterial infection, renal insufficiency, hepatic encephalopathy, gastrointestinal bleeding; - Fibrotest and actitest before, 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
Expected Total Enrollment:  342

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• adult patient of more than 18 years
• child pugh C cirrhosis

Exclusion Criteria:

• pregnant woman
• Patient received anticoagulant
• Patient treated for arterial hypertension
• Patient with severe coronaropathy
• Patient with hyper sensibility of pentoxifyllin
• 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 pentoxifyllin for 3 months before inclusion
• Patient for whom the follow-up is considered impossible

Please refer to this study by ClinicalTrials.gov identifier  NCT00162552

France
      Hôpital Beaujon, Clichy,  92110,  France; Recruiting

Study chairs or principal investigators

Didier LEBREC, MD,  Principal Investigator,  hopital Beaujon, APHP, france   

Study ID Numbers:  AOM03120 ; P030439; P030439; AFSSAPS 040593
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162552
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13