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Completed

NCT Number: NCT01637844

Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV

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.

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Key information

Conditions

HBV

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telbivudine

Drug

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

Primary outcomes

  1. HBV serologic markers and alanine transaminase (ALT) levels in infants

    Time frame: 10 months after birth

    HBsAg and HBeAg are tested in umbilical blood and peripheral blood collected at the age of 10 months respectively. ALT is measured at 10 months old.

Secondary outcomes

  1. HBV DNA quantification and ALT levels in mothers

    Time frame: Up to 10 months postpartum

    HBV DNA and ALT levels in the pregnant women are measured before taking telbivudine, at birth, 1-2 months after stopping the drug, and 10 months postpartum.

  2. Women and infants with adverse events

    Time frame: Up to 10 months after delivery/birth

    Adverse events in pregnant women during pregnancy, complications at delivery and postpartum, Apgar score, newborn infant deformity, infant growth and development will be recorded during the study period (up to 10 months after delivery/birth).

Sponsors and collaborators

Lead sponsor

Yi-Hua Zhou

Other

Collaborators

  • Fourth People's Hospital of Zhenjiang, China
  • Taixing People's Hospital
  • The First People's Hospital of Kunshan
  • Wuxi Maternal and Child Health Hospital

Registry information

Official study title

Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2012
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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