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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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