Clinical Trial: Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection

Brief Summary: 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.

Detailed Summary:
Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • interferon-γ (IFN-γ) [ Time Frame: up to 1 year ]
    the concentration of interferon-γ (IFN-γ) in serum of pregnant women,U/mL
  • Interleukin 4 (IL-4) [ Time Frame: up to 1 year ]
    the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL
  • Interleukin 6 (IL-6) [ Time Frame: up to 1 year ]
    the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL
  • T cell ratio [ Time Frame: up to 1 year ]
    T cell ratio in serum is measured by follow cytometry in pregnant women
  • 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.
  • hepatitis B e-antigen (HBeAg) [ Time Frame: up to 1 year ]
    check HBeAg in serum of pregnant women.the measure unit is PEIU/mL
  • 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.


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital Xi'an Jiaotong University

Dates:
Date Received: March 6, 2016
Date Started: March 2015
Date Completion: February 2018
Last Updated: September 23, 2016
Last Verified: September 2016