Hepatitis BNCT00845403
Antigen-specific Immune Response to Hepatitis B Virus in Utero
An observational study of Hepatitis B, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2008to 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: HBsAg+ mothers are the source of possible in utero infection.Thus, the cord blood collected from these mothers after delivery would provide information about the cause of HBV chronicity in Asian patients and about the management of baby born from HBsAg+ mothers.
Who may be able to join
- Pregnant women with HBsAg+
Who cannot join
- Pregnant women without HBsAg+
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Yap Seng Chong, MBBS, 67724286, obgcys@nus.edu.sg
Yap Seng Chong, MBBS
About this study
Official title: Antigen-specific Immune Response to Hepatitis B Virus and Influenza A (H1N1 Strain) in Utero
This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers.
Read the detailed description
Despite the development of an effective preventive HBV vaccine, the spread of HBV virus continue, particularly in Asia, where the majority of HBV infection is acquired at birth by vertical transmission from mother to baby. HBV vertical transmission has been hypothesized to cause immune tolerance to HBV and thus promoting the subsequent HBV chronicity. Such hypothesis has never been tested and nothing is known about HBV-specific adaptive immune response occurring before birth in baby born form HBV chronically infected mothers. This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers. The characterization of the HBV immune response in utero will provide informations about the cause of HBV chronicity in Asian patients in the management of baby born from HBsAg+ mothers.
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B carrier
- Medical subject headings
- Hepatitis B
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti - viral immune response in cord blood of newborn infants born to HBV+ mothers
Immune response was defined as activation of innate immune effectors (NK cells, monocytes) and production of TH1 cytokines IL - 2, TNF - a and IFN - g from T cells.
Measured: At birth (baseline)
Secondary outcomes (1)
Expression of immune genes from immune cells
Expression of immune gene cells was measured using Nanostring technology and epigenetic analysis.
Measured: At birth (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Obstetrics & Gynaecology, National University Hospital, Singapore
- Investigators
- Yap Seng Chong, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845403
- Sponsor's protocol ID
- DSRB D/08/376
- Status last verified
- Jan 2014
- First submitted
- 16 Feb 2009
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antigen-specific Immune Response to Hepatitis B Virus and Influenza A (H1N1 Strain) in Utero
- ClinicalTrials.gov ID
- NCT00845403
- Acronym / sponsor ID
- DSRB D/08/376
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B carrier
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Feb 2009 (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.
This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers.
Detailed description
Despite the development of an effective preventive HBV vaccine, the spread of HBV virus continue, particularly in Asia, where the majority of HBV infection is acquired at birth by vertical transmission from mother to baby. HBV vertical transmission has been hypothesized to cause immune tolerance to HBV and thus promoting the subsequent HBV chronicity. Such hypothesis has never been tested and nothing is known about HBV-specific adaptive immune response occurring before birth in baby born form HBV chronically infected mothers. This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers. The characterization of the HBV immune response in utero will provide informations about the cause of HBV chronicity in Asian patients in the management of baby born from HBsAg+ mothers.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- HBsAg+ mothers are the source of possible in utero infection.Thus, the cord blood collected from these mothers after delivery would provide information about the cause of HBV chronicity in Asian patients and about the management of baby born from HBsAg+ mothers.
Key inclusion criteria (1 listed)
- Pregnant women with HBsAg+
Key exclusion criteria (1 listed)
- Pregnant women without HBsAg+
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
Anti - viral immune response in cord blood of newborn infants born to HBV+ mothers
Time frame: At birth (baseline)
Immune response was defined as activation of innate immune effectors (NK cells, monocytes) and production of TH1 cytokines IL - 2, TNF - a and IFN - g from T cells.
1 secondary outcome
Expression of immune genes from immune cells
Time frame: At birth (baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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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.
Yap Seng Chong, MBBS principal investigator
National University Hospital, Singapore
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, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Jan 2014. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti - viral immune response in cord blood of newborn infants born to HBV+ mothers (time frame: At birth (baseline)). 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 13 Jan 2014.