NCT00162552

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 17, 2008

Status Verified

August 1, 2005

Enrollment Period

3.3 years

First QC Date

September 9, 2005

Last Update Submit

January 16, 2008

Conditions

CirrhosisLiver Failure

Keywords

multicenter-randomized-trialpentoxifyllinEplacebocirrhosisliver failurecytokine

Outcome Measures

Primary Outcomes (1)

  • survival rate at 2 months

    at 2 months

Secondary Outcomes (5)

  • - survival rate at 6 months

    at six months

  • - Number of patient with liver transplantation

    during the study

  • - Complications : bacterial infection, renal insufficiency, hepatic encephalopathy, gastrointestinal bleeding

    during the study

  • - Fibrotest and Acutest before, at 2 months and at 6 months

    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

    at 2 months and at 6 months as predictive factor of mortality

Study Arms (2)

1

ACTIVE COMPARATOR

Patients with severe cirrhosis treated with Pentoxifylline

Drug: pentoxifylline

2

PLACEBO COMPARATOR

Patients with severe cirrhosis treated with a placebo

Drug: PLACEBO

Interventions

pentoxifyllineDRUG

Patients with severe cirrhosis treated with Pentoxifylline

1
PLACEBODRUG

Patients with severe cirrhosis treated with a placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patient of more than 18 years
  • child pugh C cirrhosis

You may not qualify if:

  • 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 for whom the follow-up is considered impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

Location

Related Publications (1)

  • 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.

    PMID: 20102716DERIVED

MeSH Terms

Conditions

FibrosisLiver Failure

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Didier LEBREC, MD

    hopital Beaujon, APHP, france

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

August 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 17, 2008

Record last verified: 2005-08

Locations

FR(1)