Mother-to-child Hepatitis D Transmission

Completed

• Conditions: Hepatitis D; Transmission

• Registration Number: NCT02044055
• Lead Sponsor: Hopital Lariboisière

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.

Study Timeline

• Study First Submitted: 2014-01-18
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Study Start: 2014-10
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Lariboisiere; 🇫🇷 Paris, France