HBV
Conditions
Keywords
Pregnant women, HBsAg positive, HBeAg positive, Telbivudine
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.
Interventions
DRUGTelbivudine
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.
Sponsors
Taixing People's Hospital
Fourth People's Hospital of Zhenjiang, China
Wuxi Maternal and Child Health Hospital
The First People's Hospital of Kunshan
Yi-Hua Zhou
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
China
Outcome results
None listed