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

This study is currently recruiting participants.
Verified August 2012 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor:
Collaborator:
Taixing People's Hospital
Information provided by (Responsible Party):
Yi-Hua Zhou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT01637844
First received: July 4, 2012
Last updated: August 5, 2012
Last verified: August 2012

July 4, 2012
August 5, 2012
April 2012
March 2014   (final data collection date for primary outcome measure)
HBV serologic markers and alanine transaminase (ALT) levels in infants [ Time Frame: 10 months after birth ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01637844 on ClinicalTrials.gov Archive Site
  • HBV DNA quantification and ALT levels in mothers [ Time Frame: Up to 10 months postpartum ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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).
Same as current
Not Provided
Not Provided
 
Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV
Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HBV
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.
  • Experimental: Telbivudine
    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.
    Intervention: Drug: Telbivudine
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
October 2014
March 2014   (final data collection date for primary outcome measure)

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
Female
20 Years to 40 Years
No
Contact: Yi-Hua Zhou, MD, PhD +86 25 8330 4616 ext 10373 yzh20061111@yahoo.com
Contact: Yali Hu, MD, PhD +86 25 8330 4616 ext 66808 dtylhu@126.com
China
 
NCT01637844
2012019
Yes
Yi-Hua Zhou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Yi-Hua Zhou
Taixing People's Hospital
Study Director: Yali Hu, MD, PhD Nanjing Drum Tower Hospital, Nanjing University Medical School
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP