Hepatitis B, Chronic Clinical Trial
Official title:
A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection
NCT number | NCT02719808 |
Other study ID # | XJTU1AHCR2014-018 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | December 2022 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - pregnancy patients with HBeAg-positive and HBV-DNA= 106copies /ml Exclusion Criteria: - pregnancy patients with HBeAg-negative or HBV-DNA<106copies /ml |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum | Check HBV-DNA in serum by ELISA in pregnant women. The measure unit is copies/mL | up to 1 year | |
Primary | deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum | Check HBV-DNA in serum by quantitative PCR in pregnant women. The measure unit is copies/mL | up to 1 year | |
Secondary | the concentration of Interleukin 2 (IL-2) | the concentration of Interleukin 2 (IL-2)in serum of pregnant women, U/mL | up to 1 year | |
Secondary | interferon-? (IFN-?) | the concentration of interferon-? (IFN-?) in serum of pregnant women,U/mL | up to 1 year | |
Secondary | Interleukin 4 (IL-4) | the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL | up to 1 year | |
Secondary | Interleukin 6 (IL-6) | the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL | up to 1 year | |
Secondary | T cell ratio | T cell ratio in serum is measured by follow cytometry in pregnant women | up to 1 year | |
Secondary | HBV-DNA of babies | 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 | |
Secondary | hepatitis B e-antigen (HBeAg) | check HBeAg in serum of pregnant women.the measure unit is PEIU/mL | up to 1 year | |
Secondary | HBV-DNA in placenta tissue | Check HBV-DNA of placenta tissue by quantitative PCR. The measure unit is copies/mL. | the date of delivery |
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