Clinical Trial of Pentoxifylline in Patient With Cirrhosis (PENTOCIR)
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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 |
- survival rate at 2 months [ Time Frame: at 2 months ] [ Designated as safety issue: Yes ]
- - 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 |
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 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 Fibrosis Liver Failure Liver Diseases Digestive System Diseases Pathologic Processes Hepatic Insufficiency Pentoxifylline Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Vasodilator Agents Cardiovascular Agents Free Radical Scavengers Antioxidants |
ClinicalTrials.gov processed this record on May 23, 2013