- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01810835
Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.
December 5, 2013 updated by: Stephane Mouly, MD PhD, Hopital Lariboisière
Prevention of Hepatitis B Virus (HBV) Mother-to-child Transmission (MTCT): Impact of Serovaccination in Lariboisiere Hospital, Paris, France.
The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area).
The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT).
It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth.
Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.
Study Overview
Status
Completed
Conditions
Detailed Description
This monocentre, observational study will include pregnant women whom HBV-DNA is > 105 IU/mL.
HBV MTCT rates will be evaluated, according to the level of HBV-DNA in the women during the last three months of pregnancy and at childbirth (between 105 and 108 IU/mL, or > 108 IU/mL), and according to the clinical practices of serovaccination in the participating center.
The evaluation will be based on the rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth.
The rate of detectable HBV-DNA will be also evaluated in infants at the same date.
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France
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Paris, France, 75475
- Hôpital Lariboisière
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
This monocentre, observational study will include pregnant women whom HBV-DNA is > 105 IU/mL and who are not currently treated for HBV hepatitis.
Description
Inclusion Criteria:
- Pregnant woman
- whom HBs Ag +
- whom HBV-DNA >105 IU/mL
Exclusion Criteria:
- Women who have to be treated for HBV hepatitis, (AST/ALT >2 ULN without any explanation, liver biopsy performed before pregnancy showing hepatitis requiring initiation of treatment)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth
Time Frame: 9 months of life
|
9 months of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pierre O Sellier, M.D., Ph.D., Hopital Lariboisiere, Paris, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
March 12, 2013
First Submitted That Met QC Criteria
March 13, 2013
First Posted (Estimate)
March 14, 2013
Study Record Updates
Last Update Posted (Estimate)
December 6, 2013
Last Update Submitted That Met QC Criteria
December 5, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URT-Liver-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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