Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing

Completed

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT02068963

Run by

Hologic, Inc.

People needed

352

Starts

2014-02-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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