Thailand HDV Cohort

NCT ID: NCT05350865

Last Updated: 2024-10-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

3152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-30

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HDV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role collaborator

Thai Red Cross AIDS Research Centre

OTHER

Sponsor Role collaborator

Siriraj Hospital

OTHER

Sponsor Role collaborator

Taksin Hospital

UNKNOWN

Sponsor Role collaborator

Gilead Sciences

INDUSTRY

Sponsor Role collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anchalee Avihingsanon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HIV-NAT, Thai Red Cross - AIDS Research Centre

Pisit Tangkijvanich, MD

Role: PRINCIPAL_INVESTIGATOR

Biochemistry, Faculty of Medicine, Chulalongkorn University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HIV-NAT, Thai Red Cross - AIDS Research Centre

Bangkok, Bangkok, Thailand

Site Status RECRUITING

King memorial Chulalongkorn hospital

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Taksin Hospital

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chatsuda Auchieng

Role: CONTACT

6626523040 ext. 118

Pirapon J Ohata, BSc

Role: CONTACT

6626523040 ext. 147

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anchalee Avihingsanon, MD, PhD

Role: primary

6626523040 ext. 107

Chatsuda Auchieng

Role: backup

6626523040 ext. 118

Pisit Tangkijvanich, MD

Role: primary

Tawesak Tanwandee, MD

Role: primary

Supunee Jirajariyavej, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HIV-NAT 304

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.