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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02068963

Enrollment

352

Registered

2014-02-21

Start date

2014-02-28

Completion date

2015-12-31

Last updated

2016-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Puerto Rico, United States

Outcome results