Clinical Trial of Pentoxifylline in Patient With Cirrhosis (PENTOCIR)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Cirrhosis; Liver Failure

Treatments: Drug: pentoxifylline; Drug: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT00162552

P030439

AOM03120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 342 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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342 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Patients with severe cirrhosis treated with Pentoxifylline

Treatment:

Drug: pentoxifylline

2

Placebo Comparator group

Description:

Patients with severe cirrhosis treated with a placebo

Treatment:

Drug: PLACEBO