Clinical Performance Evaluation of DxN HBV Assay
- Conditions
- Hepatitis B
- Interventions
- Diagnostic Test: DxN HBV Assay
- Registration Number
- NCT03123159
- Lead Sponsor
- Beckman Coulter, Inc.
- Brief Summary
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.
- Detailed Description
Same as brief summary.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HBV Infected patients DxN HBV Assay chronic HBV patients who will undergo standard of care FDA approved antiviral therapy to treat HBV infections. Will have blood drawn to be tested using the DxN HBV Assay. Study is observational and results will not be used to manage patient care.
- Primary Outcome Measures
Name Time Method Sustained Virologic Response (SVR) Up to 48 weeks Defined as unquantifiable HBV Viral load at 48 weeks of treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Scripps Clinic
🇺🇸La Jolla, California, United States
University of Minnesota Medical School
🇺🇸Minneapolis, Minnesota, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
St. Luke's Lipid and Diabetes Research Center
🇺🇸Kansas City, Missouri, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Centre Hospitalier de l'universite de Montreal
🇨🇦Montreal, Quebec, Canada
University of Washington / Harborview Medical Center
🇺🇸Seattle, Washington, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Albert Einstein Medical School
🇺🇸Philadelphia, Pennsylvania, United States
University Health Network
🇨🇦Toronto, Ontario, Canada