Trial | NCT01637844  Report issue

Title

Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV
Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    HBV

  • Study Participants

    335
Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen (HBeAg) have an increased risk of becoming infected with HBV. This study will determine whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.
Infants of HBV-infected mothers with positive HBeAg have an increased risk of becoming infected with HBV. Standard immunoprophylaxis against mother-to-infant transmission of HBV includes administration of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine; however, approximately 5-15% of the infants are not protected despite having received these preventive measures. It is reported that antiviral prophylaxis among HBV-infected pregnant women can reduce mother-to-infant transmission of HBV. However, more research is needed to obtain the definite conclusion. This study will determine whether telbivudine among HBsAg- and HBeAg-positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.
Study Started
Apr 30
2012
Primary Completion
Oct 31
2014
Study Completion
Oct 31
2014
Last Update
Dec 02
2014
Estimate

Drug Telbivudine

HBsAg- and HBeAg-positive pregnant women at 28-32 weeks of gestation are given with telbivudine (oral 600 mg/day) until 4 weeks after delivery. Newborn infants are administered 100-200 IU HBIG within 12 hours after birth and vaccinated against hepatitis B with yeast recombinant hepatitis B vaccine (10 µg) at 0, 1, and 6-month schedule. HBV DNA and ALT levels are measured before the use of telbivudine, at delivery, and 1-2 months after stopping the drug. HBV serological markers, including HBsAg, anti-HBs, and anti-HBc, HBeAg and anti-HBe are tested in infants at age of 7-12 months.

  • Other names: Anti-HBV therapy during pregnancy

Telbivudine Experimental

HBsAg- and HBeAg-positive pregnant women at 28-32 weeks of gestation start to orally take telbivudine (600 mg/day) until 4 weeks after delivery. Newborn infants receive standard immunoprophylaxis.

Control No Intervention

Infants of HBsAg- and HBeAg-positive women who are not treated with telbivudine and any other antiviral agents serve as controls. The infants are administered standard immunoprophylaxis against mother-to-infant transmission of HBV, 100-200 IU hepatitis B immunoglobulin (HBIG) within 12 hours after birth and three doses hepatitis B vaccine at 0, 1 and 6-month schedule.

Criteria 

Inclusion Criteria:

pregnant women at 28-32 weeks of gestation
both HBsAg and HBeAg positive
good compliance

Exclusion Criteria:

Coinfection of HAV, HCV, HEV, HIV, and STD
With history of antiviral treatment against HBV
With chronic disease, such as heart and kidney disease, asthma, diabetes, hyperthyroidism, severe anemia, bleeding disease, autoimmune diseases
With threatened miscarriage or relevant treatment during the pregnancy
With pregnant complications such as pregnancy hypertension, preeclampsia, etc
With history of fetal deformity, or fetal deformity detected by ultrasound examination
With ALT >10 times upper limit, or total bilirubin >3 times upper limit, of normal value
No Results Posted