Evaluation of Paternal, Maternal and Obstetric Factors Le... | NCT02443233

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

NCT02443233

Sponsor

The University of Hong Kong

Status

Completed

Last Update Posted

Jun 12, 2017Actual

Enrollment

750Actual

Phase

Not provided

Conditions

Hepatitis B Infection

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Apr 28, 2015

First Submission Date that Met QC Criteria

May 10, 2015

First Posted Date

May 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2017

Last Update Posted Date

Jun 12, 2017Actual

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

750Actual

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Maternal and paternal hepatitis B carrier

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ka Wang Cheung	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynaecology		Hong Kong	Hong Kong	852	China

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Maternal hepatitis B carrier
Paternal hepatitis B carrier