NCT02901418

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
406

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

September 12, 2016

Last Update Submit

September 18, 2016

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis Bmother to child transmissioninterruptionhepatitis B immunoglobulinpregnancyHBsAgnewborns

Outcome Measures

Primary Outcomes (1)

  • blocking rate of vertical transmission of hepatitis B

    At the birth of 7 months, the venous blood serum HBsAg positive was defined as the failure of the interruption of HBV mother-to-child transmission.

    seven months

Secondary Outcomes (1)

  • anti HBs level at the age of one month and seven months

    one month and seven months

Study Arms (2)

control group

In this group,these children born in about two hours, we injected HBIG 200 iu and 10 micrograms of hepatitis b vaccine in their left and right thigh respectively, then injected 10 micrograms again in 1 and 6 months.

experimental group

In this group,about 2 hours after birth, respectively injecting HBIG 200 IU and 10 micrograms of hepatitis b vaccine in the right and left thigh, and in 1 and 6 months again taking 10 micrograms of standard solution, in addition, offering the additional injection of 200 IU HBIG within 24 hours.

Biological: 200 IU HBIG

Interventions

200 IU HBIGBIOLOGICAL

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

Also known as: hepatitis B immune globulin
experimental group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

In this study,the study population were composed of pregnant women suffering from chronic hepatitis B who had achieved HBeAg positive and HBV DNA \> 106 copies/ml and their newborns who were born with HBsAg positive

You may qualify if:

  • Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA \> 106 copies/ml
  • At birth the neonatal venous blood HBsAg positive

You may not qualify if:

  • Active consumption of alcohol and/or drugs
  • Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc.
  • History of autoimmune hepatitis
  • Psychiatric disease
  • Evidence of neoplastic diseases of the liver
  • without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

At the age of seven months, we extract venous blood of these children, separate the serums and collect the PBMC. Then, the serums are applied to test HBsAg, AntiHBs and HBVDNA which we adopt to analyse HLA classⅠand class Ⅱ gene polymorphism.

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

hepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yao Xie, MD

CONTACT

8610-84322489xieyao00120184@sina.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of liver diseases center

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

July 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations

CN(1)