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Trial record 156 of 517 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by The University of Hong Kong
Information provided by (Responsible Party):
The University of Hong Kong Identifier:
First received: April 28, 2015
Last updated: December 1, 2015
Last verified: December 2015

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

Hepatitis B Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • The effect of high maternal viral load on immunoprophylaxis failure, using 10^6 copies/ml as cut-off [ Time Frame: Infants' blood for HbsAg at 9-12 months old ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: January 2014
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Maternal hepatitis B carrier
Paternal hepatitis B carrier


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Maternal and paternal hepatitis B carrier

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02443233

Contact: Ka Wang Cheung (852) 22553111

China, Hong Kong
Department of Obstetrics and Gynaecology Recruiting
Hong Kong, Hong Kong, China, 852
Contact: Ka Wang Cheung    (852) 22553111   
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Ka Wang Cheung The University of Hong Kong
  More Information

Responsible Party: The University of Hong Kong Identifier: NCT02443233     History of Changes
Other Study ID Numbers: UW 13-270 
Study First Received: April 28, 2015
Last Updated: December 1, 2015
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections processed this record on September 23, 2016