NCT01788371

Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: Hua Zhang · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.

Conditions

• Hepatitis B Infection
• Chronic Infection
• Viremia

Interventions

Type	Name	Description
DRUG	Telbivudine	About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun
DRUG	Lamivudine	About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-07-01
• Completion: 2013-07-01
• First posted: 2013-02-11
• Last updated: 2013-07-30