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

  • France
      • Paris, France, 75475
        • Hôpital Lariboisiere

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
Children born to HBV-HDV women

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

  • HDV antibodies
  • if positive, HDV RNA

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)
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

Hopital Lariboisière

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.

General Publications

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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