Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Tenofovir3; Drug: Tenofovir4; Drug: Tenofovir1; Drug: Tenofovir2

• Registration Number: NCT02719808
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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 Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-25
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tenofovir3	Tenofovir3	100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one week after delivery.
Tenofovir4	Tenofovir4	100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one month after delivery.
Tenofovir1	Tenofovir1	100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one week after delivery.
Tenofovir2	Tenofovir2	100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one month after delivery.

Primary Outcome Measures

Name	Time	Method
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum	up to 1 year	Check HBV-DNA in serum by quantitative PCR in pregnant women. The measure unit is copies/mL

Secondary Outcome Measures

Name	Time	Method
interferon-γ (IFN-γ)	up to 1 year	the concentration of interferon-γ (IFN-γ) in serum of pregnant women,U/mL
Interleukin 6 (IL-6)	up to 1 year	the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL
T cell ratio	up to 1 year	T cell ratio in serum is measured by follow cytometry in pregnant women
Interleukin 4 (IL-4)	up to 1 year	the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL
hepatitis B e-antigen (HBeAg)	up to 1 year	check HBeAg in serum of pregnant women.the measure unit is PEIU/mL
HBV-DNA in placenta tissue	the date of delivery	Check HBV-DNA of placenta tissue by quantitative PCR. The measure unit is copies/mL.
the concentration of Interleukin 2 (IL-2)	up to 1 year	the concentration of Interleukin 2 (IL-2)in serum of pregnant women, U/mL
HBV-DNA of babies	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.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China