Clinical Performance Evaluation of DxN HBV Assay

Beckman Coulter

Status: Terminated

Conditions: Hepatitis B

Treatments: Diagnostic Test: DxN HBV Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT03123159

HBV-02-13

Details and patient eligibility

About

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.

Full description

Same as brief summary.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

HBV Infected patients

Description:

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.

Treatment:

Diagnostic Test: DxN HBV Assay