Mother-to-child Hepatitis D Transmission

NCT ID: NCT02044055

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis D Transmission

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Children born to HBV-HDV women

Children born to HBV-HDV co-infected women will be checked for:

* HDV antibodies
* if positive, HDV RNA

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

9 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Lariboisière

OTHER

Sponsor Role lead

Responsible Party

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Célia Lloret-Linares, MD PhD

Professor at University Paris VII Denis Diderot, physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre O SELLIER, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hopital Lariboisiere

Locations

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Hopital Lariboisiere

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 28834623 (View on PubMed)

Other Identifiers

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Liver004

Identifier Type: -

Identifier Source: org_study_id

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