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

NASH (Non-alcoholic Steato-hepatitis) Clinical Trial

Official title:

Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01406704
• Other study ID #: KCMC-04-14
• Status: Terminated
• Phase: Phase 4
• First received: July 27, 2011
• Last updated: August 18, 2011
• Start date: January 2004
• Est. completion date: December 2013

Study information

• Verified date: January 2004
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Liver
• Hepatitis
• NASH (Non-alcoholic Steato-hepatitis)

Intervention

Drug:
• 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 Thioctic acid (1800 mg/day)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological evaluation	NASH Histological scoring system	24 weeks	Yes
Secondary	Biomechanical measurement	liver function test, insulin resistance	24 weeks	Yes