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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yi-Hua Zhou
• Collaborators: Fourth People's Hospital of Zhenjiang, China; Kunshan First People Hospital; Taixing People's Hospital; Wuxi Maternal and Child Health Hospital
• Treatments: Telbivudine

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