Clinical Performance Evaluation of DxN HCV Assay

July 10, 2018 updated by: Beckman Coulter, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Same as brief

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Duluth, Georgia, United States, 30096
        • SC Liver Research Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects 18 years of age or older with chronic HCV who will undergo antiviral therapy to treat genotype 1,2 or 3 infections.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: HCV Assay
Molecular diagnostic test to detect Hepatitus C
Other Names:
  • DxN HCV Assay

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beckman Coulter, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 2, 2012

Primary Completion (Actual)

August 30, 2017

Study Completion (Actual)

August 30, 2017

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 12, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCV 2.7.3.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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