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NCT02443233 Clinical Trial

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

Hepatitis B Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02443233
Other study ID # UW 13-270
Secondary ID
Status Completed
Phase N/A
First received April 28, 2015
Last updated June 9, 2017
Start date January 2014
Est. completion date December 2016

Study information
Verified date June 2017
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Obstetrics and Gynaecology Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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