Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

Study Overview
=================
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.

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

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: Tenofovir1
* Drug: Tenofovir2
* Drug: Tenofovir3
* Drug: Tenofovir4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancy patients with HBeAg-positive and HBV-DNA≥ 106copies /ml Exclusion Criteria: pregnancy patients with HBeAg-negative or HBV-DNA<106copies /ml
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tenofovir1<br>100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one week after delivery. | Drug: Tenofovir1<br>* receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.<br>|
| Tenofovir2<br>100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one month after delivery. | Drug: Tenofovir2<br>* receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.<br>|
| Tenofovir3<br>100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one week after delivery. | Drug: Tenofovir3<br>* receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.<br>|
| Tenofovir4<br>100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one month after delivery. | Drug: Tenofovir4<br>* receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.<br>|
| Group without any treatment<br>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 | 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 | 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) | the concentration of Interleukin 2 (IL-2)in serum of pregnant women, U/mL | up to 1 year | 
| interferon-γ (IFN-γ) | the concentration of interferon-γ (IFN-γ) in serum of pregnant women,U/mL | up to 1 year | 
| Interleukin 4 (IL-4) | the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL | up to 1 year | 
| Interleukin 6 (IL-6) | the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL | up to 1 year | 
| T cell ratio | T cell ratio in serum is measured by follow cytometry in pregnant women | up to 1 year | 
| 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 | 
| hepatitis B e-antigen (HBeAg) | check HBeAg in serum of pregnant women.the measure unit is PEIU/mL | up to 1 year | 
| HBV-DNA in placenta tissue | Check HBV-DNA of placenta tissue by quantitative PCR. The measure unit is copies/mL. | the date of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vertical infection transmission, Tenofovir