Hepatitis B InfectionNCT02443233
Evaluation of Paternal, Maternal and Obstetric Factors Leading to the Hepatitis B Immunization Failure in Hong Kong
An observational study of Hepatitis B Infection, run by The University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Infection
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Maternal and paternal hepatitis B carrier
Who may be able to join
- All women age ≥ 18 years
- Maternal or paternal hepatitis B carrier
Who cannot join
- Couples will be excluded if female partners of paternal hepatitis B carrier were occult carrier
- Plan to deliver in other units
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Hepatitis B Infection
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Maternal hepatitis B carrier | Not described | |
| Paternal hepatitis B carrier | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of high maternal viral load on immunoprophylaxis failure, using 10^6 copies/ml as cut-off
Measured: Infants' blood for HbsAg at 9-12 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B InfectionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ka Wang Cheung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443233
- Sponsor's protocol ID
- UW 13-270
- Status last verified
- Jun 2017
- First submitted
- 28 Apr 2015
- Last updated
- 12 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Paternal, Maternal and Obstetric Factors Leading to the Hepatitis B Immunization Failure in Hong Kong
- ClinicalTrials.gov ID
- NCT02443233
- Acronym / sponsor ID
- UW 13-270
- Conditions
- Hepatitis B Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal hepatitis B carrier | – | – |
| Paternal hepatitis B carrier | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Maternal and paternal hepatitis B carrier
Key inclusion criteria (2 listed)
- All women age ≥ 18 years
- Maternal or paternal hepatitis B carrier
Key exclusion criteria (2 listed)
- Couples will be excluded if female partners of paternal hepatitis B carrier were occult carrier
- Plan to deliver in other units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Wang Cheung principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B Infection, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.