Hepatitt Delta-virusinfeksjon: Tverrsnittsstudie hos pasienter med kronisk hepatitt B-virusinfeksjon
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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Loc Tho Truong, MSc
- Telefonnummer: 1668 +842871026789
- E-post: loctt@tamri.vn
Studiesteder
-
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Northern Vietnam
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Hà Nội, Northern Vietnam, Vietnam, 100000
- Rekruttering
- Bach Mai General Hospital
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Ta kontakt med:
- Long Công Nguyen, Associate Professor
- Telefonnummer: +841900888866
- E-post: nguyenconglongbvbm@gmail.com
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Hà Nội, Northern Vietnam, Vietnam, 100000
- Rekruttering
- Tam Anh General Hospital
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Ta kontakt med:
- Khanh Truong Vu, MD, PhD
- Telefonnummer: 02471066858
- E-post: khanhvt@tamanhhospital.vn
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Southern Vietnam
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Ho Chi Minh City, Southern Vietnam, Vietnam, 700000
- Rekruttering
- Tam Anh TP. Ho Chi Minh General Hospital
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Ta kontakt med:
- Tran Quang Quang, Associate Professor
- Telefonnummer: 0903841479
- E-post: binhtq@hcm.tahospital.vn
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: ECOLOGIC_OR_COMMUNITY
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Pasienter med kronisk hepatitt B-virusinfeksjon
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of hepatitis D virus (HDV) in patients with chronic hepatitis B infection
Tidsramme: 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). |
Day 0 after recruitment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Distribution of the HDV genotype in patients with chronic hepatitis B infection
Tidsramme: 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. |
Day 0 after recruitment
|
|
Factors related to hepatitis D virus infection
Tidsramme: 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. |
Day 0 after recruitment
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Blodbårne infeksjoner
- Patologiske prosesser
- Kronisk sykdom
- Sykdomsattributter
- Infeksjoner
- Virussykdommer
- Sykdommer i fordøyelsessystemet
- Leversykdommer
- Hepatitt, viral, menneskelig
- Smittsomme sykdommer
- DNA-virusinfeksjoner
- Hepadnaviridae-infeksjoner
- Hepatitt, kronisk
- Hepatitt
- Patologiske tilstander, tegn og symptomer
- Hepatitt B
- Hepatitt B, kronisk
Andre studie-ID-numre
- TA-0001
Plan for individuelle deltakerdata (IPD)
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