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HDV Screening Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06889805
Enrollment
300
Registered
2025-03-21
Start date
2025-02-15
Completion date
2029-02-17
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis D Virus Infection

Keywords

HDV

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.

Interventions

None listed

Sponsors

Gilead Sciences
CollaboratorINDUSTRY
Grace Lai Hung Wong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of positive anti-HDVat screeningPrimary endpoint is seroprevalence rate of positive anti-HDV

Secondary

MeasureTime frameDescription
Prevalence rate of detectable HDV RNAat screeningPrevalence rate of detectable HDV RNA
Prevalence rate of compensated advanced chronic liver diseaseat screeningPrevalence rate of compensated advanced chronic liver disease (cACLD) defined as a liver stiffness measurement above 10.0 kPa

Countries

Hong Kong

Contacts

Primary ContactAngel Chim
angelchim@cuhk.edu.hk+85235054205

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026