ClinicalTrials.gg
RecruitingNCT06889805Updated Mar 24, 2025

HDV Screening Study

An observational study in Hepatitis D Virus Infection, sponsored by Grace Lai Hung Wong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Grace Lai Hung Wong · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Hepatitis D Virus Infection

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Keywords

  • HDV
03

In context

Hepatitis D

63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.

This study's planned enrollment of 300 is close to the median of 326 across 29 observational studies indexed under Hepatitis D.

Browse Hepatitis D studies →

Lead sponsor

This is the only study on the registry with Grace Lai Hung Wong as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Individuals with infection, i.e. anti-HIV or HIV RNA positive; AND
  2. Individuals with chronic , 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

Exclusion Criteria:

  1. Refusal to consent
  2. Age \< 18 years
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Rate of positive anti-HDV

    Primary endpoint is seroprevalence rate of positive anti-HDV

    Time frame: at screening

Secondary outcomes

  1. Prevalence rate of detectable HDV RNA

    Prevalence rate of detectable HDV RNA

    Time frame: at screening

  2. Prevalence rate of compensated advanced chronic liver disease

    Prevalence rate of compensated advanced chronic liver disease (cACLD) defined as a liver stiffness measurement above 10.0 kPa

    Time frame: at screening

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Lai JC, Wong GL, Wong VW, Yip TC. Unmet need in screening for hepatitis D virus: Time to take action. J Hepatol. 2024 Jun;80(6):e277-e278. doi: 10.1016/j.jhep.2023.12.006. Epub 2023 Dec 16. No abstract available. PubMed 38110005 ↗
  • Lui GC, Wong GL, Yang HC, Sheng WH, Lee SH. Current practice and recommendations for management of hepatitis B virus in people living with HIV in Asia. HIV Med. 2023 Oct;24(10):1035-1044. doi: 10.1111/hiv.13545. Epub 2023 Sep 21. PubMed 37735948 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2025 (actual). Primary completion is estimated for Aug 2028, 42 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2025
First posted
Mar 21, 2025
StartActual
Feb 15, 2025
Primary completionEst.
Aug 17, 2028
CompletionEst.
Feb 17, 2029
Last update
Mar 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06889805
Lead sponsor
Grace Lai Hung Wong
Collaborators
Gilead Sciences
Responsible party
Grace Lai Hung Wong (Professor, Chinese University of Hong Kong) — Sponsor-investigator
First posted
Mar 21, 2025
Start date
Feb 15, 2025
Primary completion
Aug 17, 2028 (estimated)
Completion
Feb 17, 2029 (estimated)
Last update
Mar 24, 2025

Study contacts

Angel Chim
Contact
angelchim@cuhk.edu.hk
+85235054205
Lai Hung Grace Wong
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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