Effects of Rosiglitazone and Alpha-lipoic Acid on the Pat... | NCT01406704

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

NCT01406704

Sponsor

Seoul St. Mary's Hospital

Status

Terminated

Last Update Posted

Aug 19, 2011Estimated

Enrollment

26Actual

Phase

Phase 4

Conditions

NASH (Non-alcoholic Steato-hepatitis)

Interventions

Rosiglitazone
alpha-lipoic acid
Rosiglitazone/alpha-lipoic acid

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2004

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

because of withdrawal of Avandia sale due to its risks outweigh its benefits

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2013Estimated

First Submitted Date

Jul 27, 2011

First Submission Date that Met QC Criteria

Jul 28, 2011

First Posted Date

Aug 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2011

Last Update Posted Date

Aug 19, 2011Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rosiglitazone	Drug	Rosiglitazone (8 mg/day)	Rosiglitazone	Avandia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Histological evaluation	NASH Histological scoring system	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Biomechanical measurement	liver function test, insulin resistance	24 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kun Ho Yoon	Seoul St. Mary's Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077154	Rosiglitazone
D008063	Thioctic Acid

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided