Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

Hepatitis B, Chronic Clinical Trial

Official title:

A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02719808
• Other study ID #: XJTU1AHCR2014-018
• Status: Recruiting
• Start date: March 2015
• Est. completion date: December 2022

Study information

• Verified date: November 2020
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guiqin Bai, M.D.;Ph.D.
• Phone: 86-18991232517
• Email: baigq[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic
• Infection

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

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