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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
  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
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:


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

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


Secondary Outcome Measures:
  • Biomechanical measurement [ Time Frame: 24 weeks ]
    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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Hepatitis
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Rosiglitazone
Thioctic Acid
Hypoglycemic Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 26, 2017