Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Phase 4

Completed

• Conditions: Hepatitis B Infection; Chronic Infection; Viremia
• Interventions: Drug: Lamivudine; Drug: Telbivudine

• Registration Number: NCT01788371
• Lead Sponsor: Hua Zhang

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2012-07
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 700

Inclusion Criteria

HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA>log10 copies/ml

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lamivudine	Lamivudine	lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants
Telbivudine	Telbivudine	Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg	perinatal to 28 weeks of postpartum