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

NCT ID: NCT01406704

Last Updated: 2011-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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)

Conditions

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NASH (Non-alcoholic Steato-hepatitis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Rosiglitazone

Rosiglitazone (8 mg/day)

Group Type EXPERIMENTAL

Rosiglitazone

Intervention Type DRUG

Rosiglitazone (8 mg/day)

alpha-lipoic acid

alpha-lipoic acid (1800 mg/day)

Group Type EXPERIMENTAL

alpha-lipoic acid

Intervention Type DRUG

alpha-lipoic acid (1800 mg/day)

Rosiglitazone/alpha-lipoic acid

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

Group Type EXPERIMENTAL

Rosiglitazone/alpha-lipoic acid

Intervention Type DRUG

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

Interventions

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Rosiglitazone

Rosiglitazone (8 mg/day)

Intervention Type DRUG

alpha-lipoic acid

alpha-lipoic acid (1800 mg/day)

Intervention Type DRUG

Rosiglitazone/alpha-lipoic acid

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

Intervention Type DRUG

Other Intervention Names

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Avandia Thioctic acid Avandia/Thioctic acid

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul St. Mary's Hospital

Principal Investigators

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Kun Ho Yoon

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Other Identifiers

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KCMC-04-14

Identifier Type: -

Identifier Source: org_study_id

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