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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02901418
Other study ID # Z151122224015122
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2016
Last updated September 18, 2016
Start date July 2015
Est. completion date June 2018

Study information

Verified date September 2016
Source Beijing Ditan Hospital
Contact Yao Xie, MD
Phone 8610-84322489
Email xieyao00120184@sina.com
Is FDA regulated No
Health authority China: Beijing Municipal Science and Technology Commission
Study type Observational

Clinical Trial 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.


Description:

In this trial, the study population were consisted of patients 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. Before injecting hepatitis b vaccine and HBIG for newborns, we tested their vein blood HBsAg levels, and the venous blood HBsAg positive newborns were randomly divided into the control group and the interventional group in which group we injected the additional 200 IU HBIG within 24 hours after birth, in addition to routine injection. We gathered the neonatal venous blood of 0, 7 and 30 days to test the level of anti HBs, HBsAg and HBV DNA., then detected the level of anti HBs, HBsAg and HBV DNA when these children were seven months.According to the venous blood HBsAg state of neonatus at birth, exploring the efficiency of personalized blocking method of HBV MTCT in high-risk newborns.


Recruitment information / eligibility

Status Recruiting
Enrollment 406
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

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

Locations

Country Name City State
China Beijing Ditan hospital,Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary anti HBs level at the age of one month and seven months Observing the level of anti HBs, then discussing the efficiency of personalized blocking method of HBV maternal-neonatal transmission one month and seven months Yes
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