Overview
Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
Status:
Unknown status
Unknown status
Trial end date:
2010-11-01
2010-11-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Southeast University, ChinaTreatments:
Telbivudine
Vaccines
Criteria
Inclusion Criteria:- 20-40 years old pregnant woman with gestational age of 20-32 week;
- positive serum HBsAg;
- HBV DNA≥1.0x106 copies/ml;
Exclusion Criteria:
- with previous antiviral treatment;
- with clinical sign of threatened miscarriage or related treatment in early pregnancy;
- positive serum HAV, HCV, HDV and HEV tests;
- fetus deformity by 3-D ultrasound examination;
- on other dugs, such as immune modulators, cytotoxic drugs or steroids;
- husbands are infected with HBV.