- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02044055
Mother-to-child Hepatitis D Transmission
April 26, 2017 updated by: Célia Lloret-Linares, MD PhD, Hopital Lariboisière
Hepatitis D Virus (HDV) Mother-To-Child Transmission (MTCT) From Hepatitis B Virus (HBV)-Hepatitis D Virus (HDV) Co-infected Pregnant Women: a Retrospective Study.
HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA during pregnancy.
HDV is a defective virus using HBs Ag for its own replication.
Nucleosides analogues have only a minor impact on quantitative HBs Ag level.
Data about vertical HDV transmission are old, justifying a new study.
Study Overview
Status
Completed
Conditions
Detailed Description
Hepatitis B Virus (HBV) can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA viral load during the last trimester of pregnancy.
Nucleosides analogues, lamivudine, telbivudine, or nucleotides analogues, tenofovir DF decrease HBV mother-to-child transmission risk, and are recommended in Guidelines (EASL 2012) for pregnant women with HBV DNA above 1,000 000 I.U/mL.
HDV is a defective virus using HBs Ag for its own replication.
HDV-HBV co-infection is a re-emerging infectious disease in western countries, due to immigration of people coming from endemic areas.
Nucleosides analogues have only a minor impact on quantitative HBs Ag level (Boyd A et al.
AIDS Research and Human Retroviruses 2013).
Data about vertical HDV transmission are old (Rizzetto, et al.
J Med Virol 1982), before a large use of nucleosides/nucleotides analogues in HBV infected pregnant women, justifying a new study.
Study Type
Observational
Enrollment (Actual)
54
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, 75475
- Hôpital Lariboisiere
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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
9 months to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All children born in the Maternity Department, Lariboisiere Hospital, from HBV-HDV co-infected women
Description
Inclusion Criteria:
- children born in the Maternity Department, Lariboisiere Hospital,
- from HBV-HDV co-infected women
- with a positive HDV RNA during pregnancy in the pregnant woman
Exclusion Criteria:
- negative HDV RNA during pregnancy in the pregnant woman
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
Cohorts and Interventions
Group / Cohort |
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Children born to HBV-HDV women
Children born to HBV-HDV co-infected women will be checked for:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hepatitis D antibodies (Ab) in children
Time Frame: up to 10 years (expected average: 5 years)
|
Antibodies (Ab) against Hepatitis D Virus (HDV)
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up to 10 years (expected average: 5 years)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HDV RNA in children with positive HDV Ab
Time Frame: up to 10 years (expected average: 5 years)
|
up to 10 years (expected average: 5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2014
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
January 18, 2014
First Submitted That Met QC Criteria
January 21, 2014
First Posted (Estimate)
January 23, 2014
Study Record Updates
Last Update Posted (Actual)
April 27, 2017
Last Update Submitted That Met QC Criteria
April 26, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Liver004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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