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Clinical Trial of Pentoxifylline in Patient With Cirrhosis (PENTOCIR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162552
First Posted: September 13, 2005
Last Update Posted: January 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose

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 Intervention Phase
Cirrhosis Liver Failure Drug: pentoxifylline Drug: PLACEBO Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • survival rate at 2 months [ Time Frame: at 2 months ]

Secondary Outcome Measures:
  • - survival rate at 6 months [ Time Frame: at six months ]
  • - Number of patient with liver transplantation [ Time Frame: during the study ]
  • - Complications : bacterial infection, renal insufficiency, hepatic encephalopathy, gastrointestinal bleeding [ Time Frame: during the study ]
  • - Fibrotest and Acutest before, at 2 months and at 6 months [ Time Frame: 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 ]

Enrollment: 342
Study Start Date: August 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162552


Locations
France
Hôpital Beaujon
Clichy, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Didier LEBREC, MD hopital Beaujon, APHP, france
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Saliha.DJANE, Delegation of clinical research
ClinicalTrials.gov Identifier: NCT00162552     History of Changes
Other Study ID Numbers: P030439
AOM03120
First Submitted: September 9, 2005
First Posted: September 13, 2005
Last Update Posted: January 17, 2008
Last Verified: August 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
multicenter-randomized-trial
pentoxifyllinE
placebo
cirrhosis
liver failure
cytokine

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Failure
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatic Insufficiency
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants