Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Withdrawn

• Conditions: Hepatitis B

• 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• Status: WITHDRAWN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

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 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.
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.

Trial Locations

Locations (1)

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