Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162552
Status:
COMPLETED
Last Update Posted:
2008-01-17
First Post:
2005-09-09
Brief Title:
Clinical Trial of Pentoxifylline in Patient With Cirrhosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Clinical Trial of Pentoxifylline Administration Versus Placebo on Survival in Patients With Cirrhosis and Severe Liver Failure
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PENTOCIR
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
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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOM03120 | None | None | None |