Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand
Status:
Completed
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
Summary
Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In
Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of
perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma,
even if her infant receive specific immunoglobulin and vaccine.
The hypothesis of this study is that a potent antiviral, tenofovir, can decrease HBV load in
HBV infected pregnant women and therefore reduce the risk of perinatal transmission/ Pregnant
women participating in this study will receive tenofovir or placebo during the last trimester
of pregnancy and two months postpartum. The risk of perinatal transmission will be compared
between the two groups.
The results of the study will help define policy to manage HBV infected pregnant women to
prevent perinatal transmission.
Phase:
Phase 3
Details
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborators:
Centers for Disease Control and Prevention Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Gilead Sciences