Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy

Pregnancy Clinical Trial

Official title:

Prevention of Hepatitis B Virus (HBV) Mother-to-Child (MTC) Transmission by Serovaccination of Newborns and Use of Tenofovir DF During the Last Trimester of Pregnancy in Mothers With HBV DNA Above 100, 000 I.U/mL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039362
• Other study ID #: Liver002
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2014
• Last updated: April 26, 2017
• Start date: July 2012
• Est. completion date: July 2016

Study information

• Verified date: April 2017
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around 30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from Western countries are needed.

Description:

The prevalence of HBs Ag carriage in pregnant women varies in France, according to the native country, with higher rates in those originating from sub-Saharan Africa and Asia (5 to 8% in Parisian area). The level of HBV DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). The rate of vertical transmission (Yuan J et al. J Viral Hepatitis 2006) was 0% in newborns to mothers with HBV DNA less than 100,000 copies/mL and up to more than 40% in newborns to mothers with HBV DNA above 8 Log10 copies/mL, despite serovaccination at birth, thus justifying the use of tenofovir DF during the last trimester of pregnancy in highly viraemic pregnant women, as mentionned in EASL 2012 Guidelines. Data are needed concerning the results of this strategy in western countries, justifying this prospective study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pregnant women

• positive for HBs Ag

• HBV DNA above 100,000 I.U/mL

Exclusion Criteria:

• HIV co-infection

• HDV co-infection

• requiring, according to the physician's decision, a treatment for herself and not only to prevent HBV MTC transmission

Related Conditions & MeSH terms

• HBV
• Hepatitis B
• Pregnancy

Intervention

Drug:
• Tenofovir DF
Tenofovir DF will be started at week 28 of pregnancy and stopped or not, according to the physician's decision, at week 12 after birth

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	Rate of chronically infected (positive HBs Ag) children born from mothers with HBV DNA above 100, 000 I.U/mL being given tenofovir during the last trimester of pregnancy.		At 9 months after birth