VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B
NCT06092333
Blood-Borne Infections, Chronic Disease
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT06638320
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.
Interested in participating?
Request Info16 year and older
All sexes
Observational
Bach Mai General Hospital, Hà Nội, Northern Vietnam, Vietnam
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Tam Anh Research Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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