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

Completed

• 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

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-21
• Primary Completion: 2015-04
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

Trial Locations

Locations (34)

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

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