Overview

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

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hopital Lariboisière
Treatments:
Tenofovir
Criteria
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