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

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT02443233
Collaborator
(none)
750
Enrollment
1
Location
35
Duration (Months)
21.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Maternal hepatitis B carrier
    Paternal hepatitis B carrier

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynaecology Hong Kong Hong Kong China 852

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    • Principal Investigator: Ka Wang Cheung, The University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT02443233
    Other Study ID Numbers:
    • UW 13-270
    First Posted:
    May 13, 2015
    Last Update Posted:
    Jun 12, 2017
    Last Verified:
    Jun 1, 2017
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis

    Study Results

    No Results Posted as of Jun 12, 2017