Clinical trial NCT01637844: Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV
Official title: Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HBV
Keywords: Pregnant women
HBsAg positive
HBeAg positive
Telbivudine
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Taixing People's Hospital
name: Fourth People's Hospital of Zhenjiang, China
name: Wuxi Maternal and Child Health Hospital
name: The First People's Hospital of Kunshan
First posted: 2012-07-11
Enrollment: 335
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: HBV serologic markers and alanine transaminase (ALT) levels in infants
timeFrame: 10 months after birth
Secondary outcomes:
measure: HBV DNA quantification and ALT levels in mothers
timeFrame: Up to 10 months postpartum
measure: Women and infants with adverse events
timeFrame: Up to 10 months after delivery/birth
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Taixing
country: China
facility: Taixing People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Zhenjiang Fourth People's Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Drum Tower Hospital, Nanjing University Medical School
name: Yali Hu, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Han GR, Cao MK, Zhao W, Jiang HX, Wang CM, Bai SF, Yue X, Wang GJ, Tang X, Fang ZX. A prospective and open-label study for the efficacy and safety of telbivudine in pregnancy for the prevention of perinatal transmission of hepatitis B virus infection. J Hepatol. 2011 Dec;55(6):1215-21. doi: 10.1016/j.jhep.2011.02.032. Epub 2011 Apr 15.
citation: Pan CQ, Han GR, Jiang HX, Zhao W, Cao MK, Wang CM, Yue X, Wang GJ. Telbivudine prevents vertical transmission from HBeAg-positive women with chronic hepatitis B. Clin Gastroenterol Hepatol. 2012 May;10(5):520-6. doi: 10.1016/j.cgh.2012.01.019. Epub 2012 Feb 14.
citation: Hu Y, Xu C, Xu B, Hu L, Liu Q, Chen J, Liu J, Liu L, Yang J, Chen T, Wen J, Jiang N, Zhang Y, Cao M, Feng J, Lin X, Wang Z, Xu B, Zhou YH. Safety and efficacy of telbivudine in late pregnancy to prevent mother-to-child transmission of hepatitis B virus: A multicenter prospective cohort study. J Viral Hepat. 2018 Apr;25(4):429-437. doi: 10.1111/jvh.12834. Epub 2017 Dec 26.