Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

November 16, 2020 updated by: First Affiliated Hospital Xi'an Jiaotong University

A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection

500 pregnant patients with HBeAg-positive and HBV-DNA≥ 106copies /ml who will do their pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled into the study. There will be five groups to be observed. Four groups are taking tenofovir to prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta after treating with tenofovir and explore the mechanism of tenofovir blocking HBV intrauterine infection. The safety of Tenofovir will be assessed as well.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Guiqin Bai, M.D.;Ph.D.
  • Phone Number: 86-18991232517
  • Email: baigq@126.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Guiqin Bai, M.D.;Ph.D.
          • Phone Number: 86-18991232517
          • Email: baigq@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women with HBeAg-positive and HBV-DNA>106copies/ml from the out-patient department of First Affiliated Hospital of Xi'an Jiaotong University

Description

Inclusion Criteria:

  • pregnancy patients with HBeAg-positive and HBV-DNA≥ 106copies /ml

Exclusion Criteria:

  • pregnancy patients with HBeAg-negative or HBV-DNA<106copies /ml

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tenofovir1
100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one week after delivery.
Drug: Tenofovir1
receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
Tenofovir2
100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one month after delivery.
Drug: Tenofovir2
receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
Tenofovir3
100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one week after delivery.
Drug: Tenofovir3
receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
Tenofovir4
100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one month after delivery.
Drug: Tenofovir4
receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.
Group without any treatment
100 patients don't receive any blockade therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
Time Frame: up to 1 year
Check HBV-DNA in serum by ELISA in pregnant women. The measure unit is copies/mL
up to 1 year
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
Time Frame: up to 1 year
Check HBV-DNA in serum by quantitative PCR in pregnant women. The measure unit is copies/mL
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the concentration of Interleukin 2 (IL-2)
Time Frame: up to 1 year
the concentration of Interleukin 2 (IL-2)in serum of pregnant women, U/mL
up to 1 year
interferon-γ (IFN-γ)
Time Frame: up to 1 year
the concentration of interferon-γ (IFN-γ) in serum of pregnant women,U/mL
up to 1 year
Interleukin 4 (IL-4)
Time Frame: up to 1 year
the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL
up to 1 year
Interleukin 6 (IL-6)
Time Frame: up to 1 year
the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL
up to 1 year
T cell ratio
Time Frame: up to 1 year
T cell ratio in serum is measured by follow cytometry in pregnant women
up to 1 year
HBV-DNA of babies
Time Frame: when the baby is 7-month-old
Check HBV-DNA by ELISA and quantitative PCR. The measure unit is copies/mL. All babies who used tenofovir will be tested when he is 7-month-old, in order to make sure whether they have infection during pregnant period.
when the baby is 7-month-old
hepatitis B e-antigen (HBeAg)
Time Frame: up to 1 year
check HBeAg in serum of pregnant women.the measure unit is PEIU/mL
up to 1 year
HBV-DNA in placenta tissue
Time Frame: the date of delivery
Check HBV-DNA of placenta tissue by quantitative PCR. The measure unit is copies/mL.
the date of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Guiqin Bai, M.D.;Ph.D., First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 6, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AHCR2014-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B, Chronic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe