Clinical Performance Evaluation of DxN HCV Assay
| Status: | Terminated |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/14/2018 |
| Start Date: | May 2, 2012 |
| End Date: | August 30, 2017 |
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.
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.
Same as brief
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
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