Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus

NCT01788371 Phase 4 COMPLETED

To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.

Details

Lead sponsor	Hua Zhang
Phase	Phase 4
Status	COMPLETED
Enrolment	700
Start date	2009-03
Completion	2013-07

Conditions

• Hepatitis B Infection
• Chronic Infection
• Viremia

Interventions

• Telbivudine
• Lamivudine

Primary outcomes

• The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants — perinatal to 28 weeks after infant delivery
• Its efficacy in the reduction of HBV vertical transmission rate — perinatal to 28 weeks after infant delivery