Mother-to-child Hepatitis D Transmission

Hepatitis D Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044055
• Other study ID #: Liver004
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D
• Transmission

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)