NCT05350865

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,152

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

April 22, 2022

Last Update Submit

September 30, 2024

Conditions

HDV

Keywords

HBVHDVcirrhosisThailand

Outcome Measures

Primary Outcomes (25)

  • prevalence of HDV

    prevalence of HDV in patients with cirrhosis

    1 year

  • prevalence of HDV

    prevalence of HDV in patients with non cirrhosis

    1 year

  • prevalence of HDV

    prevalence of HDV in HIV positive people with injecting drug use

    1 year

  • prevalence of HDV

    prevalence of HDV in HIV negative people with injecting drug use

    1 year

  • prevalence of HDV

    prevalence of HDV among HBV/HIV men who have sex with men

    1 year

  • prevalence of HDV

    prevalence of HDV among HBV/HIV cisgender male patients

    1 year

  • prevalence of HDV

    prevalence of HDV among prisoners

    1 year

  • proportion of participants with detectable HDV RNA among seropositive anti HDV

    proportion of participants with detectable HDV RNA among seropositive anti HDV with cirrhosis

    1 year

  • proportion of participants with detectable HDV RNA among seropositive anti HDV

    proportion of participants with detectable HDV RNA among seropositive anti HDV without cirrhosis

    1 year

  • proportion of participants with detectable HDV RNA among seropositive anti HDV

    proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID with HIV

    1 year

  • proportion of participants with detectable HDV RNA among seropositive anti HDV

    proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID without HIV

    1 year

  • proportion of participants with detectable HDV RNA among seropositive anti HDV

    proportion of participants with detectable HDV RNA among seropositive anti HDV with HIV/HBV MSM

    1 year

  • proportion of participants with detectable HDV RNA among seropositive anti HDV

    proportion of participants with detectable HDV RNA among seropositive anti HDV in HIV/HBV cisgender males

    1 year

  • proportion of participants with detectable HDV RNA among seropositive anti HDV

    proportion of participants with detectable HDV RNA among seropositive anti HDV in prisoners

    1 year

  • predictive risk of HDV infection

    predictive risk of HDV infection

    1 year

  • HDV subtype

    HDV subtype among people with cirrhosis

    1 year

  • HDV subtype

    HDV subtype among people without cirrhosis

    1 year

  • HDV subtype

    HDV subtype in PWID with HIV

    1 year

  • HDV subtype

    HDV subtype in PWID without HIV

    1 year

  • HDV subtype

    HDV subtype in HBV/HIV MSM

    1 year

  • HDV subtype

    HDV subtype in HBV/HIV cisgender males

    1 year

  • HDV subtype

    HDV subtype in prisoners

    1 year

  • performance of antiHDV commercial kits

    performance of antiHDV commercial kits

    1 year

  • prevalence of HDV among HBV/HIV before combination antiretroviral therapy

    prevalence of HDV among HBV/HIV before combination antiretroviral therapy

    1 year

  • prevalence of HDV among HBV/HIV after combination antiretroviral therapy

    prevalence of HDV among HBV/HIV after combination antiretroviral therapy

    1 year

Study Arms (1)

HDV cohort

Chronic Hepatitis B (HBsAg+) with cirrhosis (APRI \>1.5, FIB-4 \> 3.25, Fibroscan \> 12.5, imaging), PWID with HBV, HIV/HBV, HBV/HCV, aged 18 years and older

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Male or female, aged 18 years and older
  • 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
  • Provide signed and dated informed consent form.

You may not qualify if:

  • Non chronic HBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

HIV-NAT, Thai Red Cross - AIDS Research Centre

Bangkok, Bangkok, 10330, Thailand

RECRUITING

King memorial Chulalongkorn hospital

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

RECRUITING

Taksin Hospital

Bangkok, Bangkok, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The participants will have blood test for antiHD, HDV RNA, HBsAg, HBeAg, HBV DNA, antiHCV, and HIV.

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anchalee Avihingsanon, MD, PhD

    HIV-NAT, Thai Red Cross - AIDS Research Centre

    PRINCIPAL INVESTIGATOR

  • Pisit Tangkijvanich, MD

    Biochemistry, Faculty of Medicine, Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chatsuda Auchieng

CONTACT

6626523040chatsuda.a@hivnat.org

Pirapon J Ohata, BSc

CONTACT

6626523040juneohata4@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 28, 2022

Study Start

January 30, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations

TH(4)