NCT01406704

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 19, 2011

Status Verified

January 1, 2004

Enrollment Period

6.9 years

First QC Date

July 27, 2011

Last Update Submit

August 18, 2011

Conditions

NASH (Non-alcoholic Steato-hepatitis)

Outcome Measures

Primary Outcomes (1)

  • Histological evaluation

    NASH Histological scoring system

    24 weeks

Secondary Outcomes (1)

  • Biomechanical measurement

    24 weeks

Study Arms (4)

Control

NO INTERVENTION

Rosiglitazone

EXPERIMENTAL

Rosiglitazone (8 mg/day)

Drug: Rosiglitazone

alpha-lipoic acid

EXPERIMENTAL

alpha-lipoic acid (1800 mg/day)

Drug: alpha-lipoic acid

Rosiglitazone/alpha-lipoic acid

EXPERIMENTAL

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

Drug: Rosiglitazone/alpha-lipoic acid

Interventions

RosiglitazoneDRUG

Rosiglitazone (8 mg/day)

Also known as: Avandia
Rosiglitazone
alpha-lipoic acidDRUG

alpha-lipoic acid (1800 mg/day)

Also known as: Thioctic acid
alpha-lipoic acid
Rosiglitazone/alpha-lipoic acidDRUG

combination of Rosiglitazone (8 mg/day) and Thioctic acid (1800 mg/day)

Also known as: Avandia/Thioctic acid
Rosiglitazone/alpha-lipoic acid

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

RosiglitazoneThioctic Acid

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarboxylic AcidsThiophenesCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Kun Ho Yoon

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2011

First Posted

August 1, 2011

Study Start

January 1, 2004

Primary Completion

December 1, 2010

Study Completion

December 1, 2013

Last Updated

August 19, 2011

Record last verified: 2004-01