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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
HBV
Drug: Telbivudine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV

Resource links provided by NLM:


Further study details as provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 240
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637844

Contacts
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

Locations
China, Jiangsu
Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Yi-Hua Zhou, MD, PhD    +86 25 8330 4616 ext 10373    yzh20061111@yahoo.com   
Principal Investigator: Yi-Hua Zhou, MD, PhD         
Principal Investigator: Yali Hu, MD, PhD         
Taixing People's Hospital Recruiting
Taixing, Jiangsu, China, 225400
Contact: Biao Xu, MD       89110541@qq.com   
Principal Investigator: Biao Xu, MD         
Zhenjiang Fourth People's Hospital Recruiting
Zhenjiang, Jiangsu, China, 212001
Contact: Jian Wen, MD       77304270@qq.com   
Principal Investigator: Jian Wen, MD         
Sponsors and Collaborators
Yi-Hua Zhou
Taixing People's Hospital
Investigators
Study Director: Yali Hu, MD, PhD Nanjing Drum Tower Hospital, Nanjing University Medical School
  More Information

Publications:
Responsible Party: Yi-Hua Zhou, Professor of Infectious Diseases, Chair of Experimental Medicine, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT01637844     History of Changes
Other Study ID Numbers: 2012019
Study First Received: July 4, 2012
Last Updated: August 5, 2012
Health Authority: China: Ministry of Health

Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Pregnant women
HBsAg positive
HBeAg positive
Telbivudine

Additional relevant MeSH terms:
Telbivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014