Clinical Performance Evaluation of DxN HCV Assay
Terminated
- Conditions
- Hepatitis C
- 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
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
- Primary Outcome Measures
Name Time Method Sustained Virologic Response (SVR) Up to 9 months Defined as unquantifiable HCV Viral load after discontinuation of therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SC Liver Research Consortium
🇺🇸Duluth, Georgia, United States
SC Liver Research Consortium🇺🇸Duluth, Georgia, United States