Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492700
Status:
COMPLETED
Last Update Posted:
2007-06-27
First Post:
2007-06-26
Brief Title:
A One-Year Randomized Double-Blind Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
Sponsor:
Association pour la Recherche sur les Maladies Hépatiques Virales
Organization:
Association pour la Recherche sur les Maladies Hépatiques Virales
Study Overview
Official Title:
A One-Year Randomized Double-Blind Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
Status:
COMPLETED
Status Verified Date:
2007-06
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:
FLIRT
Brief Summary:
This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis NASH
Detailed Description:
Phase one A double blind randomized placebo controlled trial of rosiglitazone
64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mgday or placebo for one year
after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment
Primary endpoint improvement of at least 30 of the histological score of steatosis Secondary endpoints improvement in ALT values in necrosis and inflammation and fibrosis
Phase II extension open label trial
All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients
64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mgday or placebo for one year
after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment
Primary endpoint improvement of at least 30 of the histological score of steatosis Secondary endpoints improvement in ALT values in necrosis and inflammation and fibrosis
Phase II extension open label trial
All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients
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