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Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV
Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen (HBeAg) have an increased risk of becoming infected with HBV. This study will determine whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.
Details
| Lead sponsor | Yi-Hua Zhou |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 335 |
| Start date | 2012-04 |
| Completion | 2014-10 |
Conditions
- HBV
Interventions
- Telbivudine
Primary outcomes
- HBV serologic markers and alanine transaminase (ALT) levels in infants — 10 months after birth
HBsAg and HBeAg are tested in umbilical blood and peripheral blood collected at the age of 10 months respectively. ALT is measured at 10 months old.
Countries
China