Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

Xi'an Jiaotong University

Status: Unknown

Conditions: Hepatitis B, Chronic

Treatments: Drug: Tenofovir1; Drug: Tenofovir4; Drug: Tenofovir3; Drug: Tenofovir2

Study type: Observational

Funder types: Other

Identifiers

NCT02719808

XJTU1AHCR2014-018

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

500 participants in 5 patient groups

Tenofovir1

Description:

100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one week after delivery.

Treatment:

Drug: Tenofovir1

Tenofovir2

Description:

100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one month after delivery.

Treatment:

Drug: Tenofovir2

Tenofovir3

Description:

100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one week after delivery.

Treatment:

Drug: Tenofovir3

Tenofovir4

Description:

100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one month after delivery.

Treatment:

Drug: Tenofovir4

Group without any treatment

Description:

100 patients don't receive any blockade therapies