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

Primary Purpose

NASH (Non-alcoholic Steato-hepatitis)

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rosiglitazone
alpha-lipoic acid
Rosiglitazone/alpha-lipoic acid
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for NASH (Non-alcoholic Steato-hepatitis)

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    Rosiglitazone

    alpha-lipoic acid

    Rosiglitazone/alpha-lipoic acid

    Arm Description

    Rosiglitazone (8 mg/day)

    alpha-lipoic acid (1800 mg/day)

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

    Outcomes

    Primary Outcome Measures

    Histological evaluation
    NASH Histological scoring system

    Secondary Outcome Measures

    Biomechanical measurement
    liver function test, insulin resistance

    Full Information

    First Posted
    July 27, 2011
    Last Updated
    August 18, 2011
    Sponsor
    Seoul St. Mary's Hospital
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01406704
    Brief Title
    Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH
    Official Title
    Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2004
    Overall Recruitment Status
    Terminated
    Why Stopped
    because of withdrawal of Avandia sale due to its risks outweigh its benefits
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Seoul St. Mary's Hospital
    Collaborators
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NASH (Non-alcoholic Steato-hepatitis)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Title
    Rosiglitazone
    Arm Type
    Experimental
    Arm Description
    Rosiglitazone (8 mg/day)
    Arm Title
    alpha-lipoic acid
    Arm Type
    Experimental
    Arm Description
    alpha-lipoic acid (1800 mg/day)
    Arm Title
    Rosiglitazone/alpha-lipoic acid
    Arm Type
    Experimental
    Arm Description
    combination of Rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)
    Intervention Type
    Drug
    Intervention Name(s)
    Rosiglitazone
    Other Intervention Name(s)
    Avandia
    Intervention Description
    Rosiglitazone (8 mg/day)
    Intervention Type
    Drug
    Intervention Name(s)
    alpha-lipoic acid
    Other Intervention Name(s)
    Thioctic acid
    Intervention Description
    alpha-lipoic acid (1800 mg/day)
    Intervention Type
    Drug
    Intervention Name(s)
    Rosiglitazone/alpha-lipoic acid
    Other Intervention Name(s)
    Avandia/Thioctic acid
    Intervention Description
    combination of Rosiglitazone (8 mg/day) and Thioctic acid (1800 mg/day)
    Primary Outcome Measure Information:
    Title
    Histological evaluation
    Description
    NASH Histological scoring system
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Biomechanical measurement
    Description
    liver function test, insulin resistance
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kun Ho Yoon
    Organizational Affiliation
    Seoul St. Mary's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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