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

NCT ID: NCT06638320

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2452 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis Delta With Hepatitis B Carrier State Chronic Hepatitis b

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with chronic hepatitis B virus infection

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tam Anh Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VNVC Tan Phu

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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TA0001

Identifier Type: -

Identifier Source: org_study_id

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