Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267670
Status:
COMPLETED
Last Update Posted:
2014-09-09
First Post:
2005-12-12
Brief Title:
PentoxifyllineNonalcoholic Steatohepatitis NASH Study The Effect of Pentoxifylline on NASH
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
The Effect of Pentoxifylline on Nonalcoholic Steatohepatitis NASH
Status:
COMPLETED
Status Verified Date:
2014-08
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:
None
Brief Summary:
The purpose of this study is to explore the potential benefit of the medication pentoxifylline for the treatment of NASH
Detailed Description:
This is an investigational study looking at subjects who have been diagnosed with nonalcoholic steatohepatitis NASH or fatty liver disease There is currently no FDA approved available treatment for NASH The purpose of this study is to explore the potential benefit of the medication pentoxifylline for the treatment of NASH The effectiveness of this drug will be determined by taking blood samples and a liver biopsy To determine if there is any effect of the medication two-thirds of the patients participating in the study will receive pentoxifylline and one-third will receive placebo sugar pill Thus an individuals chance of receiving the drug is 67 In addition to receiving a study drug placebo or pentoxifylline the subjects will be encouraged to achieve modest weight loss 1-2 lbsweek via low-fat diet and exercise
The drug Pentoxifylline being studied is not approved for use in people who have NASH Pentoxifylline is considered experimental in this study Pentoxifylline has been safely used for the treatment of other medical conditions such as alcohol related liver disease and poor circulation Pentoxifylline is a pill which is taken three times a day
The drug Pentoxifylline being studied is not approved for use in people who have NASH Pentoxifylline is considered experimental in this study Pentoxifylline has been safely used for the treatment of other medical conditions such as alcohol related liver disease and poor circulation Pentoxifylline is a pill which is taken three times a day
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 |
|---|---|---|---|
| GCRC Protocol 891 | OTHER | Northwestern University Clinical Research Center | None |