NCT02443233

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2.9 years

First QC Date

April 28, 2015

Last Update Submit

June 9, 2017

Conditions

Hepatitis B Infection

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Maternal hepatitis B carrier

Paternal hepatitis B carrier

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Maternal and paternal hepatitis B carrier

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, 852, China

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Ka Wang Cheung

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 13, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations

CN(1)