Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatitis B Infection, Chronic Infection, Viremia

Intervention / Treatment
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* Drug: Telbivudine
* Drug: Lamivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA>log10 copies/ml Exclusion Criteria: co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No antiviral arm<br>provide standard of care to mothers and standard immunoprophylaxis to their infants | |
| Experimental: Lamivudine<br>lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants | Drug: Lamivudine<br>* About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum<br>|
| Experimental: Telbivudine<br>Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants | Drug: Telbivudine<br>* About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg |  | perinatal to 28 weeks of postpartum |