Clinical Performance Evaluation of DxN HBV Assay

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03123159

Enrollment

Registered

2017-04-21

Start date

2014-05-27

Completion date

2017-08-30

Last updated

2018-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

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.

Interventions

DIAGNOSTIC_TESTDxN HBV Assay

Molecular diagnostic test to detect Hepatitis B

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026