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

Chronic Hepatitis B Clinical Trial

Official title:

According to the Venous Blood HBsAg State of Neonatus at Birth, Discussing the Efficiency of Personalized Blocking Method of HBV Maternal-neonatal Transmission in High-risk Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02901418
• Other study ID #: Z151122224015122
• 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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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