Hepatitis D Virus InfectionNCT06889805
HDV Screening Study
An observational study of Hepatitis D Virus Infection, run by Grace Lai Hung Wong at 1 site in Hong Kong.
Trial summary
This is a territory-wide cross-sectional study of all individuals living with HIV/HBV coinfection and HBV-related HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D Virus Infection
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Feb 2025to 17 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals living with HIV/HBV coinfection and HBV-related HCC
Who may be able to join
- 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
Who cannot join
- Refusal to consent
- Age < 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Angel Chim, +85235054205, angelchim@cuhk.edu.hk
About this study
Official title: 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.
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.
- Conditions
- Hepatitis D Virus Infection
- Keywords
- HDV
- Medical subject headings
- Hepatitis D
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive anti-HDV
Primary endpoint is seroprevalence rate of positive anti-HDV
Measured: at screening
Secondary outcomes (2)
Prevalence rate of detectable HDV RNA
Prevalence rate of detectable HDV RNA
Measured: at screening
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
Measured: at screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start15 Feb 2025
- Primary completion17 Aug 2028 (estimated)
- Study completion17 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis D Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grace Lai Hung Wong
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor-investigator, Grace Lai Hung Wong, Chinese University of Hong Kong
- Investigators
- Lai Hung Grace Wong, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889805
- Sponsor's protocol ID
- SPEARHEAD 2024
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 38110005Lui 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Screening for Hepatitis Delta Virus (HDV) in Individuals Living with HIV/HBV Coinfection and HBV-related HCC
- ClinicalTrials.gov ID
- NCT06889805
- Acronym / sponsor ID
- SPEARHEAD 2024
- Conditions
- Hepatitis D Virus Infection
- Keywords
- HDV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Grace Lai Hung WongUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 17 Aug 2028 (estimated)
- Study completion
- 17 Feb 2029 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals living with HIV/HBV coinfection and HBV-related HCC
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to consent
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of positive anti-HDV
Time frame: at screening
Primary endpoint is seroprevalence rate of positive anti-HDV
2 secondary outcomes
Prevalence rate of detectable HDV RNA
Time frame: at screening
Prevalence rate of compensated advanced chronic liver disease
Time frame: at screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 38110005Lai 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.
- Background: PubMed 37735948Lui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lai Hung Grace Wong principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis D Virus Infection, run by Grace Lai Hung Wong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angel Chim (+85235054205, angelchim@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of positive anti-HDV (time frame: at screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06889805, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.