Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection

Conditions
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Chronic Hepatitis B, Gestation

Intervention / Treatment
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* Drug: Telbivudine
* Biological: engineered HB vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telbivudine<br>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. | Drug: Telbivudine<br>* Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.<br>* Other names: telbivudine treatment;|
| Other: Control<br>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. | Biological: engineered HB vaccine<br>* All the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months.<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery) |  | 1 month post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis B, Telbivudine, Intrauterine transmission