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Thailand HDV Cohort

Prevalence, Risk Factor and Clinical Significance of Hepatitis D Virus Infection Among Targeted High Risk Population in Thailand: Nationwide Survey 2022-2024

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05350865
Enrollment
3296
Registered
2022-04-28
Start date
2023-01-30
Completion date
2025-05-01
Last updated
2026-09-17

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

Conditions

HDV

Keywords

HBV, HDV, cirrhosis, Thailand

Brief summary

There is very limited data of HDV in Thailand. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. Therefore, this study plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. Findinds from this study will provide the scientific community to understand how important HDV is among HBV patients, this could be used to develop strategies for HDV screening and treatment

Detailed description

The prevalence of HDV remains ill-defined, mainly for lack of appropriate testing and screening. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. This data will inform the guideline whether HDV screening among HBV/HIV is required. This study has plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. This Nationwide survey of HDV is collaboration between Thai liver society, Thai AIDS society, Thai Red Cross AIDS research centre, Faculty of Medicine Chulalongkorn University, and AIDS TB and STI Control Division, Department of Disease control, MOPH Thailand. All findings will be shared and discussed to develop the National guideline for screening, treatment and care.

Interventions

None listed

Sponsors

The HIV Netherlands Australia Thailand Research Collaboration
Lead SponsorOTHER
King Chulalongkorn Memorial Hospital
CollaboratorOTHER
Thai Red Cross AIDS Research Centre
CollaboratorOTHER
Siriraj Hospital
CollaboratorOTHER
Taksin Hospital
CollaboratorUNKNOWN
Gilead Sciences
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

1. Male or female, aged 18 years and older 2. Chronically-infected with HBV, as defined by: Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result 3. Provide signed and dated informed consent form.

Exclusion criteria

Non chronic HBV

Design outcomes

Primary

MeasureTime frameDescription
prevalence of HDV1 yearprevalence of HDV in patients with cirrhosis
proportion of participants with detectable HDV RNA among seropositive anti HDV1 yearproportion of participants with detectable HDV RNA among seropositive anti HDV with cirrhosis
predictive risk of HDV infection1 yearpredictive risk of HDV infection
HDV subtype1 yearHDV subtype among people with cirrhosis
performance of antiHDV commercial kits1 yearperformance of antiHDV commercial kits
prevalence of HDV among HBV/HIV before combination antiretroviral therapy1 yearprevalence of HDV among HBV/HIV before combination antiretroviral therapy
prevalence of HDV among HBV/HIV after combination antiretroviral therapy1 yearprevalence of HDV among HBV/HIV after combination antiretroviral therapy

Countries

Thailand

Contacts

PRINCIPAL_INVESTIGATORAnchalee Avihingsanon, MD, PhD

Thai Red Cross AIDS Research Centre

PRINCIPAL_INVESTIGATORPisit Tangkijvanich, MD

Biochemistry, Faculty of Medicine, Chulalongkorn University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026