Trial | NCT00939068  Report issue

Title

Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    180
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.
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 prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.
Study Started
Feb 29
2008
Primary Completion
Jul 31
2010
Anticipated
Study Completion
Nov 30
2010
Anticipated
Last Update
Oct 14
2009
Estimate

Drug Telbivudine

Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.

  • Other names: telbivudine treatment

Biological engineered HB vaccine

All the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months.

  • Other names: control group

Telbivudine Experimental

Drug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.

Control Other

The pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.

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.
No Results Posted