Chronic Hepatitis b, Hepatitis Delta With Hepatitis B Carrier State
Conditions
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.
Interventions
None listed
Sponsors
Tam Anh Research Institute
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of hepatitis D virus (HDV) in patients with chronic hepatitis B infection | 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
| Measure | Time frame | Description |
|---|---|---|
| Distribution of the HDV genotype in patients with chronic hepatitis B infection | Day 0 after recruitment | Testing for differences in genotypic distribution between disease groups will be analyzed using the Chi-squared test. The difference is statistically significant with p \< 0.05. |
| Factors related to hepatitis D virus infection | Day 0 after recruitment | The determination of the association between risk factors and HDV will be analyzed across the total study sample. The multivariate logistic regression method will be applied in determining the variables related to the probability of HDV infection. In this analysis, HDV infection (positive or negative) is the dependent variable; Independent variables include factors that reflect demography, lifestyle, environment, occupation, clinical history (including vaccinations), and history of drug use. There are many independent variables and these variables can be correlated, determining which one affects HDV infection is a major challenge. To solve this problem, we will apply the Bayesian Model Averaging method in the R library. Based on the results of this analysis, a prognostic model of the risk of HDV infection will be established. |
Countries
Vietnam
Contacts
CONTACTLoc Tho Truong, MSc
Outcome results
None listed