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

HBV Clinical Trial

Official title:

Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637844
• Other study ID #: 2012019
• Status: Completed
• Phase: Phase 4
• First received: July 4, 2012
• Last updated: November 30, 2014
• Start date: April 2012
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HBV

Intervention

Drug:
• Telbivudine
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.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Taixing People's Hospital	Taixing	Jiangsu
China	Zhenjiang Fourth People's Hospital	Zhenjiang	Jiangsu

Sponsors (5)

Lead Sponsor	Collaborator
Yi-Hua Zhou	Fourth People's Hospital of Zhenjiang, China, Kunshan First People Hospital, Taixing People's Hospital, Wuxi Maternal and Child Health Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV serologic markers and alanine transaminase (ALT) levels in infants	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.	10 months after birth	No
Secondary	HBV DNA quantification and ALT levels in mothers	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.	Up to 10 months postpartum	No
Secondary	Women and infants with adverse events	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).	Up to 10 months after delivery/birth	Yes