Clinical Trial of Pentoxifylline in Patient With Cirrhosis

Last updated: January 16, 2008
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

3

Condition

Liver Disorders

Hepatic Fibrosis

Liver Disease

Treatment

N/A

Clinical Study ID

NCT00162552
P030439
AOM03120
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patient of more than 18 years

  • child pugh C cirrhosis

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 342
Study Start date:
August 01, 2004
Estimated Completion Date:
December 31, 2007

Study Description

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.

Connect with a study center

  • Hôpital Beaujon

    Clichy, 92110
    France

    Site Not Available

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