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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02044055

Enrollment

Registered

2014-01-23

Start date

2014-10-31

Completion date

2017-04-30

Last updated

2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis D, Transmission

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Months to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Hepatitis D antibodies (Ab) in children	up to 10 years (expected average: 5 years)	Antibodies (Ab) against Hepatitis D Virus (HDV)

Secondary

Measure	Time frame
HDV RNA in children with positive HDV Ab	up to 10 years (expected average: 5 years)

Countries

France

Outcome results