Evaluation of Paternal, Maternal and Obstetric Factors Leading to the Hepatitis B Immunization Failure in Hong Kong

Globally, hepatitis B virus (HBV) infection is the most common form of chronic hepatitis. There are still a lot of uncertainties on how infants acquired HBV leading to the development of chronic HBV infection despite active and passive immunoprophylaxis. The investigators would like to carry out a prospective study to answer the following questions:

1. the paternal, maternal and obstetric factors leading to immunoprophylaxis failure 2. the prevalence of immunoprophylaxis failure in Hong Kong

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Key information

Conditions

Hepatitis B Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Obstetrics and Gynaecology

Hong Kong, 852, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All women age ≥ 18 years
Maternal or paternal hepatitis B carrier

Exclusion criteria

Couples will be excluded if female partners of paternal hepatitis B carrier were occult carrier
Plan to deliver in other units

Treatment and study plan

Primary outcomes

The effect of high maternal viral load on immunoprophylaxis failure, using 10^6 copies/ml as cut-off

Time frame: Infants' blood for HbsAg at 9-12 months old

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: May 13, 2015
Registry last updated: Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.

Completed