Clinical Performance Evaluation of DxN HCV Assay

Clinical Utility of the DxN HCV Assay as an Aid in the Management of HCV-Infected Individuals Undergoing Antiviral Therapy

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03125408

Enrollment

210

Registered

2017-04-24

Start date

2012-05-02

Completion date

2017-08-30

Last updated

2018-07-12

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

Conditions

Hepatitis C

Brief summary

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.

Detailed description

Same as brief

Interventions

DIAGNOSTIC_TESTHCV Assay

Molecular diagnostic test to detect Hepatitus C

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Sustained Virologic Response (SVR)	Up to 9 months	Defined as unquantifiable HCV Viral load after discontinuation of therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026