NCT02719808

Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Tenofovir1	receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
DRUG	Tenofovir2	receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
DRUG	Tenofovir3	receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
DRUG	Tenofovir4	receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.

Timeline

• Start date: 2015-03-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-03-25
• Last updated: 2020-11-18

Locations

1 site across 1 country: China