Clinical Performance Evaluation of DxN HCV Assay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-02

Study Completion Date

2017-08-30

Brief Summary

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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.

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Detailed Description

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Same as brief

Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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chronic HCV Infected patients

chronic HCV patients who will undergo standard of care FDA approved antiviral therapy to treat genotype 1,2, or 3 infections and will have blood drawn at various time points and tested using the DxN HCV Assay. Study is observational and results will not be used to manage patient care.

HCV Assay

Intervention Type DIAGNOSTIC_TEST

Molecular diagnostic test to detect Hepatitus C

Interventions

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HCV Assay

Molecular diagnostic test to detect Hepatitus C

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DxN HCV Assay

Eligibility Criteria

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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.