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A Study of the Interruption on the Mother-to-child Transmission of Hepatitis B Virus （HBV MTCT）in Newborns at High Risk

NCT02901418 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 406

Last updated 2016-09-20

No results posted yet for this study

Summary

Chronic hepatitis B (CHB) is a serious liver disease worldwide，HBV MTCT is the important reason to keep high prevalence of chronic HBV infection in China. Intrapartum infection is the main period of neonatal HBV infection. Injecting HBIG and hepatitis b vaccine immediately after birth is the most important method of blocking mother-to-child transmission of HBV. However, regular doses of HBIG combined with hepatitis b vaccine blocking measures still have a failure rate as high as 5% \~ 15%.There are numerous studies to explore pregnancy women with HBV positive, especially high viral load of those women during pregnancy being treated with nucleoside analogs to increase the blocking rate of HBV MTCT, but there is still a failure rate of 2.2% to 18%. In this study, we will explore the efficiency of personalized blocking method of HBV maternal-neonatal transmission in high-risk newborns,according to the venous blood HBsAg state of neonatus at birth.

Conditions

Interventions

BIOLOGICAL

200 IU HBIG

additional 200 IU HBIG within 24 hours was used for the experimental group of newborns

Sponsors & Collaborators

  • Beijing Ditan Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02901418 on ClinicalTrials.gov