Expired Study
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Madison, Wisconsin 53792


Purpose:

The purpose of this study is to determine the effect of moderate alcohol intake on liver disease caused by HCV in terms of speed of progression as compared to those not drinking alcohol.


Criteria:

Inclusion Criteria: - Outpatient with HCV who is not receiving or planning treatment but is receiving standard of care monitoring every 3 months and is either abstinent from alcohol or drinking only moderately Exclusion Criteria: - HIV co-infection - Treated within the past 6 months - History (hx) of other liver disease - Alcohol use greater than 30 g/day or history of binge drinking in the last year - Decompensated liver disease


Study is Available At:


Original ID:

H-2004-0161


NCT ID:

NCT00205075


Secondary ID:


Study Acronym:


Brief Title:

Impact of Moderate Alcohol Use on Hepatitis C Virus (HCV) Progression


Official Title:

The Use of Validated Measures of Alcohol Intake to Measure the Impact of Moderate Alcohol Consumption on Hepatic Fibrogenesis in Individuals Infected With Hepatitis C


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Wisconsin, Madison


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

47


Enrollment Type:

Actual


Overall Contact Information

Official Name:Adnan Said, MD
Principal Investigator
University of Wisconsin, Madison

Study Dates

Start Date:August 2004
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:December 2015
Last Changed Date:December 7, 2015
First Received Date:September 13, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Control
Study Arm Type:Other
Arm Name:Case

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison

Samples and Retentions

Study Population: outpatient with HCV not receiving or planning treatment but is receiving standard of care monitoring every 3 months, abstinent or drinking
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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