Clinical Performance Evaluation of DxN HBV Assay

Stopped early

Conditions studied: Hepatitis B

In brief

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.

Key facts

Study ID

NCT03123159

Run by

Beckman Coulter, Inc.

People needed

60

Starts

2014-05-27

Expected to finish

2017-08-30

Last updated by the study team

2018-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Clinic — La Jolla, California, United States
• University of Minnesota Medical School — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• St. Luke's Lipid and Diabetes Research Center — Kansas City, Missouri, United States
• Weill Cornell Medical College — New York, New York, United States
• Albert Einstein Medical School — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Washington / Harborview Medical Center — Seattle, Washington, United States
• University Health Network — Toronto, Ontario, Canada
• Centre Hospitalier de l'universite de Montreal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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