Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

Phase 4

• Conditions: Chronic Hepatitis B, Gestation
• Interventions: Biological: engineered HB vaccine; Drug: Telbivudine

• Registration Number: NCT00939068
• Lead Sponsor: Southeast University, China

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

Detailed Description

In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-13
• Last Update Posted: 2009-10-14
• Primary Completion: 2010-07
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• 20-40 years old pregnant woman with gestational age of 20-32 week;
• positive serum HBsAg;
• HBV DNA≥1.0x106 copies/ml;

Exclusion Criteria

• with previous antiviral treatment;
• with clinical sign of threatened miscarriage or related treatment in early pregnancy;
• positive serum HAV, HCV, HDV and HEV tests;
• fetus deformity by 3-D ultrasound examination;
• on other dugs, such as immune modulators, cytotoxic drugs or steroids;
• husbands are infected with HBV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	engineered HB vaccine	The pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
Telbivudine	Telbivudine	Drug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.

Primary Outcome Measures

Name	Time	Method
the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)	1 month post partum

Secondary Outcome Measures

Name	Time	Method
liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;	1 month post partum
drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence	.1 year after childbirth