Collection of Plasma and Serum Samples From Individuals Initiating Therapy With Sofosbuvir for Chronic Hepatitis C Virus Infection for the Clinical Evaluation of the Aptima HCV Quant Dx Assay

Hologic, Inc.34 sites in 2 countries352 target enrollmentFebruary 2014

ConditionsHepatitis C

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis C
Sponsor: Hologic, Inc.
Enrollment: 352
Locations: 34
Primary Endpoint: Sustained viral response based on lower limit of quantitation
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

December 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hologic, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

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