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Trial record 16 of 304 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified July 2017 by Yao Xie, Beijing Ditan Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03209908
First Posted: July 6, 2017
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital
  Purpose
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).

Condition Intervention
Chronic Hepatitis B Drug: Tenofovir Disoproxil Fumarate

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Yao Xie, Beijing Ditan Hospital:

Primary Outcome Measures:
  • the blocking rate of vertical transmission of hepatitis B [ Time Frame: seven months ]
    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.


Secondary Outcome Measures:
  • anti HBs level at the age of one month and seven months [ Time Frame: one month and seven months ]
    Observing the level of anti HBs, then discussing the efficiency of personalized blocking method of HBV maternal-neonatal transmission


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. meanwhile, detect HBVDNA loads of pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml in 32 weeks,36 weeks of gestation and before delivery.

Estimated Enrollment: 380
Study Start Date: January 1, 2017
Estimated Study Completion Date: December 30, 2019
Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
control group
In this group, pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml don not use any antiviral drugs during pregnancy.
experimental group
pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml start to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus.
Drug: Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy
Other Name: TDF

Detailed 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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
In this study,the study population were composed of pregnant women suffering from chronic hepatitis B who had achieved HBsAg/HBeAg positive and HBV DNA > 106 copies/ml
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209908


Contacts
Contact: Yao Xie 8610-84322489 xieyao00120184@sina.com

Locations
China, Beijing
Beijing Ditan hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100015
Contact: Yao Xie, doctor    8613501093293    xieyao00120184@sina.com   
Principal Investigator: Yao Xie, doctor         
Sponsors and Collaborators
Beijing Ditan Hospital
  More Information

Responsible Party: Yao Xie, Head of liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT03209908     History of Changes
Other Study ID Numbers: XMLX201706-1
First Submitted: July 4, 2017
First Posted: July 6, 2017
Last Update Posted: July 12, 2017
Last Verified: July 2017

Keywords provided by Yao Xie, Beijing Ditan Hospital:
antiviral treatment
hepatitis B virus
mother-to-child transmission
Tenofovir Disoproxil Fumarate

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents