Clinical Performance Evaluation of DxN HBV Assay

Hepatitis B Clinical Trial

Official title:

Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03123159
• Other study ID #: HBV-02-13
• Status: Terminated
• Start date: May 27, 2014
• Est. completion date: August 30, 2017

Study information

• Verified date: July 2018
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Same as brief summary.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Diagnostic Test:
• DxN HBV Assay
Molecular diagnostic test to detect Hepatitis B

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'universite de Montreal	Montreal	Quebec
Canada	University Health Network	Toronto	Ontario
United States	Baylor College of Medicine	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	St. Luke's Lipid and Diabetes Research Center	Kansas City	Missouri
United States	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	Albert Einstein Medical School	Philadelphia	Pennsylvania
United States	University of Washington / Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virologic Response (SVR)	Defined as unquantifiable HBV Viral load at 48 weeks of treatment.	Up to 48 weeks