Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
- Conditions
- Hepatitis C
- Registration Number
- NCT02068963
- Lead Sponsor
- Hologic, Inc.
- Brief Summary
This non-interventional clinical study will be conducted to prospectively collect serial plasma and serum samples from treatment naïve subjects with chronic HCV infection who are initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of HCV-infected patients undergoing HCV antiviral therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
-
The subject is chronically infected with HCV genotypes 1, 2, 3, 4, 5, and/or 6 as documented in the subject's medical records and is naïve to HCV treatment (treatment naïve).
-
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)
- Subjects with history or evidence of decompensated liver disease
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained viral response based on lower limit of quantitation 12 weeks post therapy Sustained viral response (SVR) is defined as viral load level being below the investigational assay's lower limit of quantitation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Franco Felizarta, MD
🇺🇸Bakersfield, California, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Commonwealth Clinical Studies
🇺🇸Brockton, Massachusetts, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
South Denver Gastroenterology, PC
🇺🇸Englewood, Colorado, United States
Empire Clinical Research
🇺🇸Upland, California, United States
Island View Gastroenterology
🇺🇸Ventura, California, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Austin Center for Clinical Research
🇺🇸Austin, Texas, United States
Infectious Diseases Associates of Central Virginia
🇺🇸Lynchburg, Virginia, United States
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Kaiser Permanente
🇺🇸San Francisco, California, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Schiff Center for Liver Disease
🇺🇸Miami, Florida, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, 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
Indianapolis Gastroenterology Research Facility
🇺🇸Indianapolis, Indiana, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Kansas City Gastroenterology
🇺🇸Kansas City, Missouri, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, 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
The Texas Liver Institute
🇺🇸San Antonio, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States