Clinical Performance Evaluation of DxN HCV Assay

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03125408
• Other study ID #: HCV 2.7.3.001
• Status: Terminated
• Start date: May 2, 2012
• Est. completion date: August 30, 2017

Study information

• Verified date: July 2018
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Same as brief

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 210
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Diagnostic Test:
• HCV Assay
Molecular diagnostic test to detect Hepatitus C

Locations

Country	Name	City	State
United States	SC Liver Research Consortium	Duluth	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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