Clinical Performance Evaluation of DxN HBV Assay
| Status: | Terminated |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/14/2018 |
| Start Date: | May 27, 2014 |
| End Date: | August 30, 2017 |
Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy
The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in
the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the
study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the
intended use population.
the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the
study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the
intended use population.
Same as brief summary.
Inclusion Criteria:
- Subject is 18 years of age or older
- Subject has serological evidence of chronic HBV infection, and measurable HBV-DNA and
ALT at baseline
- Subject will undergo treatment with tenofovir or entecavir for a minimum of 48 weeks
Exclusion Criteria:
- Co-infection with HIV or HCV at enrollment
- Subject has decompensated liver disease or liver cancer
- Prior participation in study
- Current or planned participation in an investigational drug or device study
We found this trial at
9
sites
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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