The Study of Short-range Antiviral Treatment During Pregnancy to Block Mother-to-child Transmission of Hepatitis B Virus and Withdrawal Time

Chronic Hepatitis B Clinical Trial

Official title:

The Study of Starting to Use Tenofovir Disoproxil Fumarate(TDF) Antiviral Treatment From the 32 Weeks of Gestation to Block Mother-to-child Transmission of Hepatitis B Virus(HBV MTCT) and Withdrawal Time

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209908
• Other study ID #: XMLX201706-1
• Status: Recruiting
• Phase: N/A
• First received: July 4, 2017
• Last updated: July 10, 2017
• Start date: January 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2017
• Source: Beijing Ditan Hospital
• Contact: Yao Xie
• Phone: 8610-84322489
• Email: xieyao00120184[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pregnant women carry high HBV DNA loads before delivery, which is the most important factor leading to mother-to-child transmission of HBV. Nucleoside analogue antiviral treatment during late pregnancy can significantly reduce the incidence of HBV MTCT, but security problems of using NA treatment during pregnancy has not been eliminated, Therefore, the aim of our study is to explore the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

Description:

HBV MTCT is the important reason to keep high prevalence of chronic HBV infection in China; high HBV DNA loads of Pregnant women before delivery is the most important factor resulting in mother-to-child transmission of HBV, therefore, how to drop HBV DNA levels of pregnant women before delivery to the level that can markedly decrease the rate of HBV MTCT on the base of HBIG combined hepatitis b vaccine injection for newborns, which is the most important method to improve HBV MTCT. Although Nucleoside analogue antiviral treatment during late pregnancy can dramatically reduce the rate of HBV MTCT, security problems of NA treatment during pregnancy has not been demonstrated, On account of the above problems, our study is to investigate the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• 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

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy

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	the 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	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