Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV
|ClinicalTrials.gov Identifier: NCT01637844|
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|HBV||Drug: Telbivudine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||335 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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.
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 Name: Anti-HBV therapy during pregnancy
No Intervention: Control
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.
- 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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637844
|Nanjing Drum Tower Hospital|
|Nanjing, Jiangsu, China, 210008|
|Taixing People's Hospital|
|Taixing, Jiangsu, China, 225400|
|Zhenjiang Fourth People's Hospital|
|Zhenjiang, Jiangsu, China, 212001|
|Study Director:||Yali Hu, MD, PhD||Nanjing Drum Tower Hospital, Nanjing University Medical School|