NCT01743079

Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: Beijing YouAn Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

Detailed description

This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA \> 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.

Conditions

• Chronic Hepatitis B
• Late Pregnancy
• Transmission
• Complication

Interventions

Type	Name	Description
DRUG	Telbivudine	LdT 600mg QD
DRUG	Lamivudine	LAM 100mg QD

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-12-06
• Last updated: 2013-07-30

Locations

1 site across 1 country: China