PENTOCIR: Clinical Trial of Pentoxifylline in Patient With Cirrhosis

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00162552

Collaborator

(none)

342

Enrollment

Location

Arms

Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Liver Failure	Drug: pentoxifylline Drug: PLACEBO	Phase 3

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

342 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

survival rate at 2 months [at 2 months]

Secondary Outcome Measures

- 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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