Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH

Phase 4

Terminated

• Conditions: NASH (Non-alcoholic Steato-hepatitis)
• Interventions: Drug: Rosiglitazone; Drug: alpha-lipoic acid; Drug: Rosiglitazone/alpha-lipoic acid

• Registration Number: NCT01406704
• Lead Sponsor: Seoul St. Mary's Hospital

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)

Study Timeline

• Status Verified: 2004-01
• Study Start: 2004-01
• Primary Completion: 2010-12
• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-08-01
• Last Update Submitted: 2011-08-18
• Last Update Posted: 2011-08-19
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosiglitazone	Rosiglitazone	Rosiglitazone (8 mg/day)
alpha-lipoic acid	alpha-lipoic acid	alpha-lipoic acid (1800 mg/day)
Rosiglitazone/alpha-lipoic acid	Rosiglitazone/alpha-lipoic acid	combination of Rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)

Primary Outcome Measures

Name	Time	Method
Histological evaluation	24 weeks	NASH Histological scoring system

Secondary Outcome Measures

Name	Time	Method
Biomechanical measurement	24 weeks	liver function test, insulin resistance