Clinical Trial of Pentoxifylline in Patient With Cirrhosis
NCT ID: NCT00162552
Last Updated: 2008-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
342 participants
INTERVENTIONAL
2004-08-31
2007-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Patients with severe cirrhosis treated with Pentoxifylline
pentoxifylline
Patients with severe cirrhosis treated with Pentoxifylline
2
Patients with severe cirrhosis treated with a placebo
PLACEBO
Patients with severe cirrhosis treated with a placebo
Interventions
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pentoxifylline
Patients with severe cirrhosis treated with Pentoxifylline
PLACEBO
Patients with severe cirrhosis treated with a placebo
Eligibility Criteria
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Inclusion Criteria
* child pugh C cirrhosis
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Delegation of clinical research
Principal Investigators
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Didier LEBREC, MD
Role: PRINCIPAL_INVESTIGATOR
hopital Beaujon, APHP, france
Locations
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Hôpital Beaujon
Clichy, , France
Countries
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References
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Lebrec D, Thabut D, Oberti F, Perarnau JM, Condat B, Barraud H, Saliba F, Carbonell N, Renard P, Ramond MJ, Moreau R, Poynard T; Pentocir Group. Pentoxifylline does not decrease short-term mortality but does reduce complications in patients with advanced cirrhosis. Gastroenterology. 2010 May;138(5):1755-62. doi: 10.1053/j.gastro.2010.01.040. Epub 2010 Jan 25.
Other Identifiers
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AOM03120
Identifier Type: -
Identifier Source: secondary_id
P030439
Identifier Type: -
Identifier Source: org_study_id
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