Clinical Trial of Pentoxifylline in Patient With Cirrhosis (PENTOCIR)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00162552
First received: September 9, 2005
Last updated: January 16, 2008
Last verified: August 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

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
Other Name: pentoxifylline
Placebo Comparator: 2
Patients with severe cirrhosis treated with a placebo
Drug: PLACEBO
Patients with severe cirrhosis treated with a placebo
Other Name: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: September 9, 2005
Last Updated: January 16, 2008
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014