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Clinical Trials/NCT06889805
NCT06889805
Recruiting
Not Applicable

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

Grace Lai Hung Wong1 site in 1 country300 target enrollmentStarted: February 15, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
1
Primary Endpoint
Rate of positive anti-HDV
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Individuals with HIV infection, i.e. anti-HIV or HIV RNA positive; AND
  • •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
  • •Aged 18 years old or above.
  • •Written or verbal consent obtained

Exclusion Criteria

  • •Refusal to consent
  • •Age \< 18 years

Outcomes

Primary Outcomes

Rate of positive anti-HDV

Time Frame: at screening

Primary endpoint is seroprevalence rate of positive anti-HDV

Secondary Outcomes

  • Prevalence rate of detectable HDV RNA(at screening)
  • Prevalence rate of compensated advanced chronic liver disease(at screening)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Grace Lai Hung Wong

Professor

Chinese University of Hong Kong

Study Sites (1)

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