HDV Screening Study

March 20, 2025 updated by: Grace Lai Hung Wong

Universal Screening for Hepatitis Delta Virus (HDV) in Individuals Living with HIV/HBV Coinfection and HBV-related HCC

This is a territory-wide cross-sectional study of all individuals living with HIV/HBV coinfection and HBV-related HCC.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Chronic hepatitis B virus (HBV) infection remains endemic in Hong Kong with an estimated prevalence of 6.2% in the recent Population Health Survey 2020-2022.1 The estimated prevalence of chronic HBV infection among individuals living with HIV is 8%.2 Yet, no data are available concerning the disease burden of hepatitis delta virus (HDV) among individuals living with HIV/HBV coinfection.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals living with HIV/HBV coinfection and HBV-related HCC

Description

Inclusion Criteria:

  1. Individuals with HIV infection, i.e. anti-HIV or HIV RNA positive; AND
  2. Individuals with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart; AND
  3. Aged 18 years old or above.
  4. Written or verbal consent obtained

Exclusion Criteria:

  1. Refusal to consent
  2. Age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of positive anti-HDV
Time Frame: at screening
Primary endpoint is seroprevalence rate of positive anti-HDV
at screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence rate of detectable HDV RNA
Time Frame: at screening
Prevalence rate of detectable HDV RNA
at screening
Prevalence rate of compensated advanced chronic liver disease
Time Frame: at screening
Prevalence rate of compensated advanced chronic liver disease (cACLD) defined as a liver stiffness measurement above 10.0 kPa
at screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grace Lai Hung Wong

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Lai Hung Grace Wong, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2025

Primary Completion (Estimated)

August 17, 2028

Study Completion (Estimated)

February 17, 2029

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPEARHEAD 2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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