Efficacy of Antiviral Therapy in Pregnancy in Preventing Vertical Transmission of HBV in Mothers With a High Viral Load

• Conditions: Immune Globulin, Prophylaxis, Telbuvidine, Vaccine
• Interventions: Drug: telbivudine

• Registration Number: NCT02253485
• Lead Sponsor: Beijing Ditan Hospital

Brief Summary

Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV) infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg positive mothers with high serum HBV DNA loads.

Detailed Description

This study contain 600 patients and compose groups as follow: (ⅰ) infants born to a HBsAg positive mothers with high HBV DNA load before delivery receive standard immunoprophylaxis( injection of HBIG 200IU at birth plus HBV vaccine at 0,1 and 6month); (ⅱ) infants born to a HBsAg positive mother with high HBV DNA load before delivery, and based on standard immunoprophylaxis receive addition injection of HBIG 200IU at 1 month after birth; (ⅲ) infants born to a HBsAg positive and high HBV DNA load mothers but treated with antiviral therapy in late pregnancy, receive standard immunoprophylaxis; (ⅳ) infants born to a HBsAg positive mothers treated with antiviral therapy during entire pregnancy for hepatitis receive standard immunoprophylaxis; (ⅴ) infants born to a HBsAg positive mother with serum HBV DNA negative receive standard immunoprophylaxis.

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-29
• Last Update Submitted: 2014-09-29
• Study First Posted: 2014-10-01
• Last Update Posted: 2014-10-01
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• infants born to HBsAg positive mother HBsAg positive mother

Exclusion Criteria

• mothers coinfected HIV or HCV

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
telbivudine treated in late pregnancy	telbivudine	mothers with high serum HBV DNA load were treated with antiviral therapy in late pregnancy, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.
telbivudine treated entire pregnancy	telbivudine	mothers in this group were treated with antiviral therapy during entire pregnancy for hepatitis, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.

Primary Outcome Measures

Name	Time	Method
mother-to-child transmission of HBV	7 months	HBV infenction in infants at 7 months after birth