Status:
TERMINATED
Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH
Lead Sponsor:
Seoul St. Mary's Hospital
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
NASH (Non-alcoholic Steato-hepatitis)
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
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-l...
Eligibility Criteria
Inclusion
- the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)
Exclusion
- alcohol consumption \> 20g/day
- viral hepatitis B and C
- autoimmune hepatitis
- Wilson's disease
- hemochromatosis
- alpha-1 antitrypsin deficiency
- breast-feeding or pregnant females
- subjects planning to become pregnant
- severe comorbid medical conditions (such as severe cardiac, pulmonary, renal or psychological problems)
- those not consenting for the study
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01406704
Start Date
January 1 2004
End Date
December 1 2013
Last Update
August 19 2011
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