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

This study has been terminated.
(because of withdrawal of Avandia sale due to its risks outweigh its benefits)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01406704
First received: July 27, 2011
Last updated: August 18, 2011
Last verified: January 2004
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • Histological evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    NASH Histological scoring system


Secondary Outcome Measures:
  • Biomechanical measurement [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    liver function test, insulin resistance


Enrollment: 26
Study Start Date: January 2004
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406704

Sponsors and Collaborators
Seoul St. Mary's Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Kun Ho Yoon Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Kun Ho Yoon/principal investigator, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01406704     History of Changes
Other Study ID Numbers: KCMC-04-14
Study First Received: July 27, 2011
Last Updated: August 18, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Fatty Liver
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Thioctic Acid
 Rosiglitazone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hypoglycemic Agents

ClinicalTrials.gov processed this record on June 18, 2013