Clinical Trial of Pentoxifylline in Patient With Cirrhosis

Cirrhosis Clinical Trial

— PENTOCIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162552
• Other study ID #: P030439
• Secondary ID: AOM03120
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: January 16, 2008
• Start date: August 2004
• Est. completion date: December 2007

Study information

• Verified date: August 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis
• Liver Failure

Intervention

Drug:
• pentoxifylline
Patients with severe cirrhosis treated with Pentoxifylline
• PLACEBO
Patients with severe cirrhosis treated with a placebo

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate at 2 months		at 2 months	Yes
Secondary	- survival rate at 6 months		at six months	Yes
Secondary	- Number of patient with liver transplantation		during the study	Yes
Secondary	- Complications : bacterial infection, renal insufficiency, hepatic encephalopathy, gastrointestinal bleeding		during the study	Yes
Secondary	- Fibrotest and Acutest before, at 2 months and at 6 months		at 2 months and at 6 months	Yes
Secondary	- 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	Yes