335
Participants
Start Date
April 30, 2012
Primary Completion Date
October 31, 2014
Study Completion Date
October 31, 2014
Telbivudine
HBsAg- and HBeAg-positive pregnant women at 28-32 weeks of gestation are given with telbivudine (oral 600 mg/day) until 4 weeks after delivery. Newborn infants are administered 100-200 IU HBIG within 12 hours after birth and vaccinated against hepatitis B with yeast recombinant hepatitis B vaccine (10 µg) at 0, 1, and 6-month schedule. HBV DNA and ALT levels are measured before the use of telbivudine, at delivery, and 1-2 months after stopping the drug. HBV serological markers, including HBsAg, anti-HBs, and anti-HBc, HBeAg and anti-HBe are tested in infants at age of 7-12 months.
Nanjing Drum Tower Hospital, Nanjing
Zhenjiang Fourth People's Hospital, Zhenjiang
Taixing People's Hospital, Taishing
Taixing People's Hospital
OTHER
Fourth People's Hospital of Zhenjiang, China
OTHER
Wuxi Maternal and Child Health Hospital
UNKNOWN
The First People's Hospital of Kunshan
OTHER
Yi-Hua Zhou
OTHER