Clinical Performance Evaluation of DxN HCV Assay

Beckman Coulter, Inc.210 enrolled

Overview

The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in the management of of HCV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HCV Assay for plasma samples in the intended use population.

Same as brief

Study Type

OBSERVATIONAL

Enrollment

210

Conditions

Hepatitis C

Interventions

HCV AssayDIAGNOSTIC_TEST

Molecular diagnostic test to detect Hepatitus C

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is 18 years of age or older * Subject has measurable HCV-RNA at baseline (prior to treatment start) * Subject is genotype 2 or 3 and plans to undergo treatment with Peginterferon (PEG) plus Ribavirin (RBV) or Sofosbuvir (SOF) plus RIB * Subject is genotype 1 and plans to undergo treatment with Telaprevir (TEL) or SOF plus PEG+RBV or, SOF plus Ledipasivr (LED) * Subject is able to under information given, and willing and able to voluntarily give their consent to participate in study including signing consent form. Exclusion Criteria: * Co-infection with HIV or Hepatitis B (HBV) * Prior participation in study * Current participation in an investigation drug or device study

Locations (1)

SC Liver Research Consortium

Duluth, Georgia, United States

Outcomes

Primary Outcomes

Sustained Virologic Response (SVR)

Defined as unquantifiable HCV Viral load after discontinuation of therapy

Time frame: Up to 9 months

Data from ClinicalTrials.gov

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