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

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 and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

Detailed Description
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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.

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

Conditions
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Chronic Hepatitis B, Late Pregnancy, Transmission, Complication

Intervention / Treatment
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* Drug: Telbivudine
* Drug: Lamivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 20-40 years old HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml Gestational age: 26-28 weeks with normal fetus Willing to consent for the study Exclusion Criteria: Elevated ALT Antiviral treatment experience patients Co-infection with HAV, HCV,HDV, HIV Concurrent treatment with immune modulators, cytotoxic drugs, or steroids Clinical signs of threatened miscarriage in early pregnancy Clinical evidence of cirrhosis and/or hepatocellular carcinoma

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telbivudine<br>Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis | Drug: Telbivudine<br>* LdT 600mg QD<br>* Other names: LdT;|
| Experimental: Lamivudine<br>Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis. | Drug: Lamivudine<br>* LAM 100mg QD<br>* Other names: LAM;|
| No Intervention: No antiviral treatment<br>Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child |  | From gestation week 26 to postpartum week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion |  | From gestation week 26 to pastpartume week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telbivudine, Lamivudine, safety, efficacy, pregnancy