Status:
UNKNOWN
Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
Lead Sponsor:
Southeast University, China
Conditions:
Chronic Hepatitis B, Gestation
Eligibility:
FEMALE
20-40 years
Phase:
PHASE4
Brief 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.
Detailed Description
In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels ...
Eligibility Criteria
Inclusion
- 20-40 years old pregnant woman with gestational age of 20-32 week;
- positive serum HBsAg;
- HBV DNA≥1.0x106 copies/ml;
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00939068
Start Date
February 1 2008
End Date
November 1 2010
Last Update
October 14 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.