Clinical Trial of Pentoxifylline in Patient With Cirrhosis (PENTOCIR)

January 16, 2008 updated by: Assistance Publique - Hôpitaux de Paris

Clinical Trial of Pentoxifylline Administration Versus Placebo on Survival in Patients With Cirrhosis and Severe Liver Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clichy, France, 92110
        • Hôpital Beaujon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients with severe cirrhosis treated with Pentoxifylline
Drug: pentoxifylline
Patients with severe cirrhosis treated with Pentoxifylline
Placebo Comparator: 2
Patients with severe cirrhosis treated with a placebo
Drug: PLACEBO
Patients with severe cirrhosis treated with a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival rate at 2 months
Time Frame: at 2 months
at 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
- survival rate at 6 months
Time Frame: at six months
at six months
- Number of patient with liver transplantation
Time Frame: during the study
during the study
- Complications : bacterial infection, renal insufficiency, hepatic encephalopathy, gastrointestinal bleeding
Time Frame: during the study
during the study
- Fibrotest and Acutest before, at 2 months and at 6 months
Time Frame: 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
Time Frame: at 2 months and at 6 months as predictive factor of mortality
at 2 months and at 6 months as predictive factor of mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

January 17, 2008

Last Update Submitted That Met QC Criteria

January 16, 2008

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P030439
  • AOM03120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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