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

NCT01637844 | Completed Phase 4 DMC

• 1 other identifier: 2012019
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 3

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.

Conditions

HBV

Keywords

Pregnant women; HBsAg positive; HBeAg positive; Telbivudine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• HBV DNA quantification and ALT levels in mothers

  Up to 10 months postpartum

• Women and infants with adverse events

  Up to 10 months after delivery/birth

Study Arms (2)

Telbivudine

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Telbivudine DRUG

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.

Also known as: Anti-HBV therapy during pregnancy

Telbivudine

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women at 28-32 weeks of gestation
• both HBsAg and HBeAg positive
• good compliance

You may not qualify if:

• 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

Sponsors & Collaborators

• Yi-Hua Zhou: lead
• Taixing People's Hospital: collaborator
• Fourth People's Hospital of Zhenjiang, China: collaborator
• Wuxi Maternal and Child Health Hospital: collaborator
• The First People's Hospital of Kunshan: collaborator

Study Sites (3)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Taixing People's Hospital

Taishing, Jiangsu, 225400, China

Location

Zhenjiang Fourth People's Hospital

Zhenjiang, Jiangsu, 212001, China

Location

Related Publications (3)

• 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.

  PMID: 21703206 BACKGROUND

• 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.

  PMID: 22343511 BACKGROUND

• 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.

  PMID: 29193547 DERIVED

MeSH Terms

Interventions

Telbivudine

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yali Hu, MD, PhD

  Nanjing Drum Tower Hospital, Nanjing University Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Infectious Diseases, Chair of Experimental Medicine

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 11, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

CN (3)