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OpenTrials
Completed

NCT Number: NCT02044055

Mother-to-child Hepatitis D Transmission

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.

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Key information

Age range

9 month–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Lariboisiere

Paris, 75475, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hepatitis D antibodies (Ab) in children

    Time frame: up to 10 years (expected average: 5 years)

    Antibodies (Ab) against Hepatitis D Virus (HDV)

Secondary outcomes

  1. HDV RNA in children with positive HDV Ab

    Time frame: up to 10 years (expected average: 5 years)

Sponsors and collaborators

Lead sponsor

Hopital Lariboisière

Other

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2014
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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