Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV
- Registration Number
- NCT01637844
- Lead Sponsor
- Yi-Hua Zhou
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 335
- pregnant women at 28-32 weeks of gestation
- both HBsAg and HBeAg positive
- good compliance
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telbivudine Telbivudine 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.
- Primary Outcome Measures
Name Time Method HBV serologic markers and alanine transaminase (ALT) levels in infants 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 Outcome Measures
Name Time Method Women and infants with adverse events 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).
HBV DNA quantification and ALT levels in mothers 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.
Trial Locations
- Locations (3)
Taixing People's Hospital
🇨🇳Taixing, Jiangsu, China
Zhenjiang Fourth People's Hospital
🇨🇳Zhenjiang, Jiangsu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China