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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02044055
Other study ID # Liver004
Secondary ID
Status Completed
Phase N/A
First received January 18, 2014
Last updated April 26, 2017
Start date October 2014
Est. completion date April 2017

Study information

Verified date April 2017
Source Hopital Lariboisière
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 9 Months to 15 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
France Hopital Lariboisiere Paris

Sponsors (1)

Lead Sponsor Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hepatitis D antibodies (Ab) in children Antibodies (Ab) against Hepatitis D Virus (HDV) up to 10 years (expected average: 5 years)
Secondary HDV RNA in children with positive HDV Ab up to 10 years (expected average: 5 years)
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