Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV

PHASE4CompletedINTERVENTIONAL
Enrollment

335

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
HBV
Interventions
DRUG

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.

Trial Locations (3)

210008

Nanjing Drum Tower Hospital, Nanjing

212001

Zhenjiang Fourth People's Hospital, Zhenjiang

225400

Taixing People's Hospital, Taishing

All Listed Sponsors
collaborator

Taixing People's Hospital

OTHER

collaborator

Fourth People's Hospital of Zhenjiang, China

OTHER

collaborator

Wuxi Maternal and Child Health Hospital

UNKNOWN

collaborator

The First People's Hospital of Kunshan

OTHER

lead

Yi-Hua Zhou

OTHER

NCT01637844 - Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV | Biotech Hunter | Biotech Hunter