Mother-to-child Hepatitis D Transmission

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Hopital Lariboisière
Sponsor:
Information provided by (Responsible Party):
Stephane Mouly, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT02044055
First received: January 18, 2014
Last updated: January 21, 2014
Last verified: January 2014
  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 Hopital Lariboisière:

Primary Outcome Measures:
  • Hepatitis D antibodies (Ab) in children [ Time Frame: up to 10 years (expected average: 5 years) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   9 Months to 15 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044055

Contacts
Contact: Pierre O SELLIER, M.D., Ph.D 00 33 149956339 pierre.sellier@lrb.aphp.fr

Locations
France
Hopital Lariboisiere Not yet recruiting
Paris, France, 75475
Contact: Pierre O SELLIER, M.D., Ph.D    00 33 149956339    pierre.sellier@lrb.aphp.fr   
Principal Investigator: Pierre O SELLIER, M.D., Ph.D         
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Principal Investigator: Pierre O SELLIER, M.D., Ph.D Hopital Lariboisiere
  More Information

No publications provided

Responsible Party: Stephane Mouly, MD PhD, Professor at University Paris VII Denis Diderot, physician, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT02044055     History of Changes
Other Study ID Numbers: Liver004
Study First Received: January 18, 2014
Last Updated: January 21, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on September 16, 2014