Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT01406704
Status:
TERMINATED
Last Update Posted:
2011-08-19
First Post:
2011-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH
Sponsor:
Seoul St. Mary's Hospital
Organization:
Study Overview
Official Title:
Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)
Status:
TERMINATED
Status Verified Date:
2004-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
because of withdrawal of Avandia sale due to its risks outweigh its benefits
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).
Detailed Description:
Duration: 24 week-intervention Study Group: Four arms
* Control: no intervention
* Rosiglitazone: rosiglitazone (8 mg/day)
* alpha-lipoic acid: alpha-lipoic acid (1800 mg/day)
* Rosiglitazone/alpha-lipoic acid: combination of rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)
* Control: no intervention
* Rosiglitazone: rosiglitazone (8 mg/day)
* alpha-lipoic acid: alpha-lipoic acid (1800 mg/day)
* Rosiglitazone/alpha-lipoic acid: combination of rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)
Study Oversight
Has Oversight DMC:
True
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?: