Clinical trial NCT05350865: Thailand HDV Cohort
Official title: Prevalence, Risk Factor and Clinical Significance of Hepatitis D Virus Infection Among Targeted High Risk Population in Thailand: Nationwide Survey 2022-2024
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HDV
Keywords: HBV
HDV
cirrhosis
Thailand
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: King Chulalongkorn Memorial Hospital
name: Thai Red Cross AIDS Research Centre
name: Siriraj Hospital
name: Taksin Hospital
name: Gilead Sciences
First posted: 2022-04-28
Enrollment: 3152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of HDV
timeFrame: 1 year
measure: prevalence of HDV
timeFrame: 1 year
measure: prevalence of HDV
timeFrame: 1 year
measure: prevalence of HDV
timeFrame: 1 year
measure: prevalence of HDV
timeFrame: 1 year
measure: prevalence of HDV
timeFrame: 1 year
measure: prevalence of HDV
timeFrame: 1 year
measure: proportion of participants with detectable HDV RNA among seropositive anti HDV
timeFrame: 1 year
measure: proportion of participants with detectable HDV RNA among seropositive anti HDV
timeFrame: 1 year
measure: proportion of participants with detectable HDV RNA among seropositive anti HDV
timeFrame: 1 year
measure: proportion of participants with detectable HDV RNA among seropositive anti HDV
timeFrame: 1 year
measure: proportion of participants with detectable HDV RNA among seropositive anti HDV
timeFrame: 1 year
measure: proportion of participants with detectable HDV RNA among seropositive anti HDV
timeFrame: 1 year
measure: proportion of participants with detectable HDV RNA among seropositive anti HDV
timeFrame: 1 year
measure: predictive risk of HDV infection
timeFrame: 1 year
measure: HDV subtype
timeFrame: 1 year
measure: HDV subtype
timeFrame: 1 year
measure: HDV subtype
timeFrame: 1 year
measure: HDV subtype
timeFrame: 1 year
measure: HDV subtype
timeFrame: 1 year
measure: HDV subtype
timeFrame: 1 year
measure: HDV subtype
timeFrame: 1 year
measure: performance of antiHDV commercial kits
timeFrame: 1 year
measure: prevalence of HDV among HBV/HIV before combination antiretroviral therapy
timeFrame: 1 year
measure: prevalence of HDV among HBV/HIV after combination antiretroviral therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT, Thai Red Cross - AIDS Research Centre
city: Bangkok
country: Thailand
facility: King memorial Chulalongkorn hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Taksin Hospital
Study officials:
affiliation: HIV-NAT, Thai Red Cross - AIDS Research Centre
name: Anchalee Avihingsanon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biochemistry, Faculty of Medicine, Chulalongkorn University
name: Pisit Tangkijvanich, MD
role: PRINCIPAL_INVESTIGATOR
References: