Clinical Performance Evaluation of DxN HBV Assay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-27

Study Completion Date

2017-08-30

Brief Summary

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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.

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Detailed Description

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Same as brief summary.

Conditions

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Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HBV Infected patients

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.

DxN HBV Assay

Intervention Type DIAGNOSTIC_TEST

Molecular diagnostic test to detect Hepatitis B

Interventions

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DxN HBV Assay

Molecular diagnostic test to detect Hepatitis B

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No