Clinical Performance Evaluation of DxN HCV Assay

Terminated

• Conditions: Hepatitis C
• Interventions: Diagnostic Test: HCV Assay

• Registration Number: NCT03125408
• Lead Sponsor: Beckman Coulter, Inc.

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

Study Timeline

• Study Start: 2012-05-02
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Primary Completion: 2017-08-30
• Study Completion: 2017-08-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic HCV Infected patients	HCV Assay	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

SC Liver Research Consortium; 🇺🇸 Duluth, Georgia, United States