Impact of Moderate Alcohol Use on Hepatitis C Virus (HCV)... | NCT00205075

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

NCT00205075

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Dec 9, 2015Estimated

Enrollment

47Actual

Phase

Not provided

Conditions

Hepatic Fibrogenesis
Hepatitis C

Interventions

Not provided

Countries

United States

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

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

Dec 7, 2015

Last Update Posted Date

Dec 9, 2015Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

outpatient with HCV not receiving or planning treatment but is receiving standard of care monitoring every 3 months, abstinent or drinking

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adnan Said, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53792	United States

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Case
Control