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Gilead Sustained Virologic Re...

Gilead Sustained Virologic Response (SVR) Registry

Last Updated: 2018-08-31

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

COMPLETED

Total Enrollment

6625 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-13

Study Completion Date

2018-01-08

Brief Summary

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This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead oral antiviral agent (OAV)
* Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol
* Provide written, informed consent
* Be willing and able to comply with the visit schedule and protocol-mandated procedures

Exclusion Criteria

* Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry
* History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Birmingham Gastroenterology Associates

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Digestive Health Specialists of the Southeast, PA

Dothan, Alabama, United States

Site Status

Mayo Clinic

Phoenix, Arizona, United States

Site Status

The University of Arizona

Tucson, Arizona, United States

Site Status

Advanced Clinical Research Institute, LLC

Anaheim, California, United States

Site Status

Franco Felizarta, MD

Bakersfield, California, United States

Site Status

Southern California Liver Centers

Coronado, California, United States

Site Status

West Coast Clinical Trials, LLC

Costa Mesa, California, United States

Site Status

Scripps Clinic Medical Group

La Jolla, California, United States

Site Status

eStudySite

La Mesa, California, United States

Site Status