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

NCT ID: NCT01637844

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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HBV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Telbivudine

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Anti-HBV therapy during pregnancy

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Taixing People's Hospital

OTHER

Sponsor Role collaborator

Fourth People's Hospital of Zhenjiang, China

OTHER

Sponsor Role collaborator

Wuxi Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Kunshan

OTHER

Sponsor Role collaborator

Yi-Hua Zhou

OTHER

Sponsor Role lead

Responsible Party

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Yi-Hua Zhou

Professor of Infectious Diseases, Chair of Experimental Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yali Hu, MD, PhD

Role: STUDY_DIRECTOR

Nanjing Drum Tower Hospital, Nanjing University Medical School

Locations

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Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status

Taixing People's Hospital

Taishing, Jiangsu, China

Site Status

Zhenjiang Fourth People's Hospital

Zhenjiang, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 21703206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22343511 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29193547 (View on PubMed)

Other Identifiers

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2012019

Identifier Type: -

Identifier Source: org_study_id