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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02443233

Enrollment

750

Registered

2015-05-13

Start date

2014-01-31

Completion date

2016-12-31

Last updated

2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Infection

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The effect of high maternal viral load on immunoprophylaxis failure, using 10^6 copies/ml as cut-off	Infants' blood for HbsAg at 9-12 months old

Countries

China

Outcome results