Clinical Performance Evaluation of DxN HCV Assay

Beckman Coulter

Status: Terminated

Conditions: Hepatitis C

Treatments: Diagnostic Test: HCV Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT03125408

HCV 2.7.3.001

Details and patient eligibility

About

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.

Full description

Same as brief

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

210 participants in 1 patient group

chronic HCV Infected patients

Description:

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.

Treatment:

Diagnostic Test: HCV Assay