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Recruiting NCT06638320

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

Observational Hepatitis Delta With Hepatitis B Carrier State Chronic Hepatitis b

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hepatitis Delta With Hepatitis B Carrier State, Chronic Hepatitis b. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Prevalence of hepatitis D virus (HDV) in patients with chronic hepatitis B infection [Time frame: Day 0 after recruitment]
Secondary outcome measures (2)
  • Distribution of the HDV genotype in patients with chronic hepatitis B infection [Time frame: Day 0 after recruitment]
  • Factors related to hepatitis D virus infection [Time frame: Day 0 after recruitment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Ecologic or community

Study locations

Vietnam · 3 centers
  • Bach Mai General Hospital — Hà Nội
  • Tam Anh General Hospital — Hà Nội
  • Tam Anh TP. Ho Chi Minh General Hospital — Ho Chi Minh City

Identifiers

NCT: NCT06638320 · TA-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗