Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection

NCT06638320 | Recruiting

• 1 other identifier: TA-0001
• Study Type: observational
• Target: 2,452
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this observational study is to determine the prevalence of hepatitis D virus (HDV) and the distribution of the HDV genotype in patients with chronic hepatitis B infection. It will also identify factors related to hepatitis D virus infection, such as characteristics of the study sample, vaccination history, drug use affecting hepatitis, family factors, environment, and lifestyle. This study will be conducted at Tam Anh General Hospital, Bach Mai Hospital and Tam Anh TP. Ho Chi Minh General Hospital. Participants will be interviewed directly through a questionnaire to collect some information related to epidemiological risk factors. A blood sample will also be collected.

Conditions

Hepatitis Delta With Hepatitis B Carrier State; Chronic Hepatitis b

Outcome Measures

Primary Outcomes (1)

• Prevalence of hepatitis D virus (HDV) in patients with chronic hepatitis B infection

  The method of estimating prevalence based on the assumption of binary distribution will be applied to the entire study sample and each subgroup. The prevalence rate will be estimated by dividing the number of positive cases by the sample size. The 95% confidence interval of the prevalence will be calculated based on the binary distribution assumption. Prevalence will be estimated for each sex, age, and disease group (chronic hepatitis B, chronic hepatitis B with hepatocellular carcinoma, and cirrhosis).

  Day 0 after recruitment

Secondary Outcomes (2)

• Distribution of the HDV genotype in patients with chronic hepatitis B infection

  Day 0 after recruitment

• Factors related to hepatitis D virus infection

  Day 0 after recruitment

Study Arms (1)

Patients with chronic hepatitis B virus infection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥ 16 years old with chronic hepatitis B, with hepatocellular carcinoma and cirrhosis or not, should be examined and treated at the Gastroenterology - Hepatobiliary Center of Bach Mai Hospital, Tam Anh General Hospital and Tam Anh TP. Ho Chi Minh General Hospital.

You may qualify if:

• Patients ≥ 16 years old undergo testing at the Testing Center of Tam Anh General Hospital or Tam Anh TP. Ho Chi Minh General Hospital, with chronic hepatitis B HBsAg (+) standards for six months or over or HBsAg (+) combined with HBcAb total (+) and HBcAb-immunoglobulin M (-).
• Patients ≥ 16 years old with chronic hepatitis B come to be examined or are inpatients at the Gastroenterology - Hepatobiliary Center of Bach Mai Hospital, diagnosed with hepatocellular carcinoma, and cirrhosis

You may not qualify if:

• Patients do not agree to participate in the study or refuse to sign a written informed consent.

Sponsors & Collaborators

• Tam Anh Research Institute: lead

Study Sites (3)

Bach Mai General Hospital

Hà Nội, Northern Vietnam, 100000, Vietnam

RECRUITING

Tam Anh General Hospital

Hà Nội, Northern Vietnam, 100000, Vietnam

RECRUITING

Tam Anh TP. Ho Chi Minh General Hospital

Ho Chi Minh City, Southern Vietnam, 700000, Vietnam

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Loc Tho Truong, MSc

CONTACT

+842871026789; loctt@tamri.vn

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion: July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 22, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (3)