HDV Screening Study

NCT ID: NCT06889805

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-15

Study Completion Date

2029-02-17

Brief Summary

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

Detailed Description

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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

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Hepatitis D Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Grace Lai Hung Wong

OTHER

Sponsor Role lead

Responsible Party

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Grace Lai Hung Wong

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lai Hung Grace Wong

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Angel Chim

Role: CONTACT

+85235054205

Facility Contacts

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Angel Chim

Role: primary

+85235054205

References

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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.

Reference Type BACKGROUND
PMID: 38110005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37735948 (View on PubMed)

Other Identifiers

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SPEARHEAD 2024

Identifier Type: -

Identifier Source: org_study_id

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