Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Tam Anh Research Institute
- Enrollment
- 2,452
- Locations
- 1
- Primary Endpoint
- Prevalence of hepatitis D virus (HDV) in patients with chronic hepatitis B infection
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients do not agree to participate in the study or refuse to sign a written informed consent.
Outcomes
Primary Outcomes
Prevalence of hepatitis D virus (HDV) in patients with chronic hepatitis B infection
Time Frame: Day 0 after recruitment
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).
Secondary Outcomes
- 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)