Mother-to-child Hepatitis D Transmission
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.
1 other identifier
observational
54
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 27, 2017
April 1, 2017
2.5 years
January 18, 2014
April 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hepatitis D antibodies (Ab) in children
Antibodies (Ab) against Hepatitis D Virus (HDV)
up to 10 years (expected average: 5 years)
Secondary Outcomes (1)
HDV RNA in children with positive HDV Ab
up to 10 years (expected average: 5 years)
Study Arms (1)
Children born to HBV-HDV women
Children born to HBV-HDV co-infected women will be checked for: * HDV antibodies * if positive, HDV RNA
Eligibility Criteria
All children born in the Maternity Department, Lariboisiere Hospital, from HBV-HDV co-infected women
You may qualify if:
- 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
You may not qualify if:
- negative HDV RNA during pregnancy in the pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Lariboisiere
Paris, 75475, France
Related Publications (1)
Sellier PO, Maylin S, Brichler S, Bercot B, Lopes A, Chopin D, Pogliaghi M, Munier AL, Delcey V, Simoneau G, Evans J, Gordien E, Simon F, Bergmann JF. Hepatitis B Virus-Hepatitis D Virus mother-to-child co-transmission: A retrospective study in a developed country. Liver Int. 2018 Apr;38(4):611-618. doi: 10.1111/liv.13556. Epub 2017 Sep 12.
PMID: 28834623DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre O SELLIER, M.D., Ph.D
Hopital Lariboisiere
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor at University Paris VII Denis Diderot, physician
Study Record Dates
First Submitted
January 18, 2014
First Posted
January 23, 2014
Study Start
October 1, 2014
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
April 27, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share