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

NCT03209908 | Unknown

• 1 other identifier: XMLX201706-1
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Hepatitis B

Keywords

antiviral treatment; hepatitis B virus; mother-to-child transmission; Tenofovir Disoproxil Fumarate

Outcome Measures

Primary Outcomes (1)

• 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 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, 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

Interventions

Tenofovir Disoproxil Fumarate DRUG

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

Also known as: TDF

experimental group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA \> 106 copies/ml

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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

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. 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.

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Yao Xie

CONTACT

8610-84322489; xieyao00120184@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: July 4, 2017
• First Posted: July 6, 2017
• Study Start: January 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

CN (1)