Mother-to-child Hepatitis D Transmission

Sponsor

Hopital Lariboisière (Other)

Overall Status

Completed

CT.gov ID

NCT02044055

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis D Transmission

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 Design

Study Type:

Observational

Actual Enrollment :

54 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official 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.

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Children born to HBV-HDV women Children born to HBV-HDV co-infected women will be checked for: HDV antibodies if positive, HDV RNA

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

HDV RNA in children with positive HDV Ab [up to 10 years (expected average: 5 years)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Months to 15 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Lariboisiere	Paris		France	75475

Sponsors and Collaborators

Hopital Lariboisière

Investigators

Principal Investigator: Pierre O SELLIER, M.D., Ph.D, Hopital Lariboisiere

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Célia Lloret-Linares, MD PhD, Professor at University Paris VII Denis Diderot, physician, Hopital Lariboisière

ClinicalTrials.gov Identifier:

NCT02044055

Other Study ID Numbers:

Liver004

First Posted:

Jan 23, 2014

Last Update Posted:

Apr 27, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Hepatitis A

Hepatitis D

Hepatitis

Study Results

No Results Posted as of Apr 27, 2017