Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Withdrawn

• Conditions: Hepatitis B
• Interventions: Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay; Diagnostic Test: Point of Care ALT; Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spot

• Registration Number: NCT04289428
• Lead Sponsor: Kirby Institute

Brief Summary

Evaluation of novel point of care Hepatitis B diagnostic assays.

Detailed Description

This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility;

* GeneXpert HBV DNA via Fingerstick testing,

* Dried Blood Spot based HBV DNA

* Point of care ALT.

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-12-03
• Study Start: 2022-01
• Primary Completion: 2022-07
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Have voluntarily signed the informed consent form.
2. 18 years of age or older.
3. HBsAg positive
4. Part A: Not currently on antiviral therapy for HBV and HBV DNA detectable OR Part B: Stable on HBV antiviral therapy for at least 3 months with HBV DNA < 20 IU/ml

Exclusion Criteria

1. Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	Xpert® HBV DNA fingerstick point of care assay	Stable on HBV antiviral therapy for at least 3 months with HBV DNA \< 20 IU/ml
B	Point of Care ALT	Stable on HBV antiviral therapy for at least 3 months with HBV DNA \< 20 IU/ml
A	Xpert® HBV DNA fingerstick point of care assay	Not currently on antiviral therapy for HBV and HBV DNA detectable
B	Xpert® HBV DNA point of care assay from dried blood spot	Stable on HBV antiviral therapy for at least 3 months with HBV DNA \< 20 IU/ml
A	Point of Care ALT	Not currently on antiviral therapy for HBV and HBV DNA detectable
A	Xpert® HBV DNA point of care assay from dried blood spot	Not currently on antiviral therapy for HBV and HBV DNA detectable

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay	Through study completion, an average of 1 year	To evaluate the sensitivity and specificity of the Xpert® HBV DNA point of care assay from finger-stick whole blood samples compared to plasma samples collected via venipuncture and tested on the Roche COBAS AmpliPrep/COBAS TaqMan HBV (CAP/CTM HBV) V2 assay.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the point of care ALT	Through study completion, an average of 1 year	To evaluate the sensitivity and specificity of the point of care ALT assay from finger-stick whole blood samples compared to standard of care ALT collected via venepuncture.
Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots	Through study completion, an average of 1 year	To evaluate the sensitivity and specificity of the Xpert® HBV DNA point of care assay from dried blood spot samples compared to plasma samples collected via venipuncture and tested on the Roche COBAS AmpliPrep/COBAS TaqMan HBV (CAP/CTM HBV) V2 assay.

Trial Locations

Locations (1)

St. Vincent's Hospital Sydney; 🇦🇺 Darlinghurst, New South Wales, Australia