Clinical Trial of Pentoxifylline in Patient With Cirrhosis | NCT00162552

Studies
Clinical Trial of Pentoxifylline in Patient With Cirrhosis

NCT00162552

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jan 17, 2008Estimated

Enrollment

342Actual

Phase

Phase 3

Conditions

Cirrhosis
Liver Failure

Interventions

pentoxifylline
PLACEBO

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AOM03120

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2008

Last Update Posted Date

Jan 17, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

342Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
pentoxifylline	Drug	Patients with severe cirrhosis treated with Pentoxifylline	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival rate at 2 months		at 2 months

Secondary Outcomes

Measure	Description	Time Frame
- 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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Didier LEBREC, MD	hopital Beaujon, APHP, france	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Beaujon		Clichy		92110	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20102716	Derived	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.

ID	Term
D005355	Fibrosis
D017093	Liver Failure

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D048550	Hepatic Insufficiency
D008107	Liver Diseases

ID	Term
D013805	Theobromine
D014970	Xanthines
D011688	Purinones
D011687	Purines
D006574