Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Hepatitis B Clinical Trial

Official title:

Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04289428
• Other study ID #: VHCRP2001
• Status: Withdrawn
• Start date: January 2022
• Est. completion date: October 2022

Study information

• Verified date: November 2021
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of novel point of care Hepatitis B diagnostic assays.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Diagnostic Test:
• Xpert® HBV DNA fingerstick point of care assay
Xpert® HBV DNA point of care assay from finger-stick whole blood
• Point of Care ALT
Point of Care ALT from finger-stick whole blood
• Xpert® HBV DNA point of care assay from dried blood spot
Xpert® HBV DNA point of care assay from dried blood spot

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay	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.	Through study completion, an average of 1 year
Secondary	Sensitivity and specificity of the point of care ALT	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.	Through study completion, an average of 1 year
Secondary	Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots	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.	Through study completion, an average of 1 year