Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
NCT ID: NCT02068963
Last Updated: 2016-02-04
Study Results
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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COMPLETED
352 participants
OBSERVATIONAL
2014-02-28
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study Population
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Chronic HCV (with or without HIV \[human immunodeficiency virus\] co-infection) will be documented with historical record of:
* A positive HCV RNA test result (result generated at least 6 months before the baseline visit)
* A HCV genotype test result (result generated at least 6 months before the baseline visit)
* A liver biopsy report demonstrating chronic HCV
---The subject is initiating antiviral therapy with a sofosbuvir regimen as indicated below:
* Sofosbuvir plus peginterferon and ribavirin for 12 weeks (peginterferon eligible genotype 1, 4, 5, or 6)
* Sofosbuvir plus ribavirin for 12 weeks (genotype 2)
* Sofosbuvir plus ribavirin for 24 weeks (peginterferon ineligible or unwilling genotype 1 or genotype 3)
* The subject is at least 18 years of age at the time of enrollment
* Adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
* The subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
Exclusion Criteria
* Subjects with severe renal impairment or end stage renal disease
* Subjects who are not naïve to HCV therapy with prior exposure to an approved or experimental HCV antiviral therapy
* Subject has characteristics that are contraindicated in the FDA approved label for sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or ribavirin, pregnant woman or men whose female partners are pregnant; Sovaldi Package Insert 2013)
* Subject is receiving treatment pre- or post-transplant
* Subject is unsuitable for study participation based on the Investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
* Participating in another investigational study that the Investigator believes might interfere with the subject's participation in this study
18 Years
ALL
No
Sponsors
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Hologic, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christine Kuslich
Role: STUDY_DIRECTOR
Hologic, Inc.
Locations
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Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Franco Felizarta, MD
Bakersfield, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Kaiser Permanente
San Francisco, California, United States
Empire Clinical Research
Upland, California, United States
Island View Gastroenterology
Ventura, California, United States
South Denver Gastroenterology, PC
Englewood, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Schiff Center for Liver Disease
Miami, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Indianapolis Gastroenterology Research Facility
Indianapolis, Indiana, United States
Investigative Clinical Research
Annapolis, Maryland, United States
Mercy Medical Center
Baltimore, Maryland, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
Kansas City Gastroenterology
Kansas City, Missouri, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
Charleston GI Specialists
Charleston, South Carolina, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Quality Medical Research, PLLC
Nashville, Tennessee, United States
Central Texas Clinical Research
Austin, Texas, United States
Austin Center for Clinical Research
Austin, Texas, United States
Cure C Consortium
Houston, Texas, United States
Liver Associates of Texas, P.A.
Houston, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
The Texas Liver Institute
San Antonio, Texas, United States
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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Other Identifiers
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P10433-HCVQPS-01
Identifier Type: -
Identifier Source: org_study_id
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