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Mother-to-child Hepatitis D Transmission

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02044055
First Posted: January 23, 2014
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Célia Lloret-Linares, MD PhD, Hopital Lariboisière
  Purpose
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
Hepatitis D Transmission

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Célia Lloret-Linares, MD PhD, Hopital Lariboisière:

Primary Outcome Measures:
  • Hepatitis D antibodies (Ab) in children [ Time Frame: 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 [ Time Frame: up to 10 years (expected average: 5 years) ]

Enrollment: 54
Study Start Date: October 2014
Study Completion Date: April 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children born to HBV-HDV women

Children born to HBV-HDV co-infected women will be checked for:

  • HDV antibodies
  • if positive, HDV RNA

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children born in the Maternity Department, Lariboisiere Hospital, from HBV-HDV co-infected women
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044055


Locations
France
Hopital Lariboisiere
Paris, France, 75475
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Principal Investigator: Pierre O SELLIER, M.D., Ph.D Hopital Lariboisiere
  More Information

Responsible Party: Célia Lloret-Linares, MD PhD, Professor at University Paris VII Denis Diderot, physician, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT02044055     History of Changes
Other Study ID Numbers: Liver004
First Submitted: January 18, 2014
First Posted: January 23, 2014
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis D
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections