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Recruiting

NCT Number: NCT06889805

HDV Screening Study

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

Recruiting

Interested in participating?

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Key information

Conditions

Hepatitis D Virus Infection Digestive System Diseases Hepatitis Hepatitis D Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of positive anti-HDV

    Time frame: at screening

    Primary endpoint is seroprevalence rate of positive anti-HDV

Secondary outcomes

  1. Prevalence rate of detectable HDV RNA

    Time frame: at screening

    Prevalence rate of detectable HDV RNA

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Angel Chim

CONTACT

[email protected]

+85235054205

Sponsors and collaborators

Lead sponsor

Grace Lai Hung Wong

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 21, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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