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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01406704
Recruitment Status : Terminated (because of withdrawal of Avandia sale due to its risks outweigh its benefits)
First Posted : August 1, 2011
Last Update Posted : August 19, 2011
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Seoul St. Mary's Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
NASH (Non-alcoholic Steato-hepatitis) Drug: Rosiglitazone Drug: alpha-lipoic acid Drug: Rosiglitazone/alpha-lipoic acid Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)
Study Start Date : January 2004
Actual Primary Completion Date : December 2010
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Experimental: Rosiglitazone
Rosiglitazone (8 mg/day)
 Drug: Rosiglitazone
Rosiglitazone (8 mg/day)
Other Name: Avandia
Experimental: alpha-lipoic acid
alpha-lipoic acid (1800 mg/day)
 Drug: alpha-lipoic acid
alpha-lipoic acid (1800 mg/day)
Other Name: Thioctic acid
Experimental: Rosiglitazone/alpha-lipoic acid
combination of Rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)
 Drug: Rosiglitazone/alpha-lipoic acid
combination of Rosiglitazone (8 mg/day) and Thioctic acid (1800 mg/day)
Other Name: Avandia/Thioctic acid


Outcome Measures
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Primary Outcome Measures :
  1. Histological evaluation [ Time Frame: 24 weeks ]
    NASH Histological scoring system


Secondary Outcome Measures :
  1. Biomechanical measurement [ Time Frame: 24 weeks ]
    liver function test, insulin resistance


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406704


Sponsors and Collaborators
Seoul St. Mary's Hospital
GlaxoSmithKline
Investigators
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Principal Investigator: Kun Ho Yoon Seoul St. Mary's Hospital
More Information
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Responsible Party: Kun Ho Yoon/principal investigator, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01406704    
Other Study ID Numbers: KCMC-04-14
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: January 2004
Additional relevant MeSH terms:
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Hepatitis
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Thioctic Acid
Rosiglitazone
Hypoglycemic Agents
 Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients