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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Immune Globulin, Prophylaxis, Telbuvidine, Vaccine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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telbivudine treated entire pregnancy

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.

telbivudine

Intervention Type DRUG

in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B.

in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV.

telbivudine treated in late pregnancy

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

Intervention Type DRUG

in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B.

in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV.

HBV DNA positive control

infants in this group born to mother with high serum HBV DNA load and receive standard immunoprophylaxis or additional HBIG injection at 1 month after birth for preventing MTCT of HBV.

No interventions assigned to this group

HBV DNA negative control

infants in this group born to a HBsAg positive and serum HBV DNA negative mothers and receive standard immunoprophylaxis for preventing MTCT of HBV

No interventions assigned to this group

Interventions

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telbivudine

in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B.

in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV.

Intervention Type DRUG