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Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

NCT ID: NCT02719808

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Hepatitis B, Chronic

Keywords

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Vertical infection transmission Tenofovir

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tenofovir1

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

Tenofovir1

Intervention Type DRUG

receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.

Tenofovir2

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

Tenofovir2

Intervention Type DRUG

receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.

Tenofovir3

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

Tenofovir3

Intervention Type DRUG

receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.

Tenofovir4

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

Tenofovir4

Intervention Type DRUG

receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.

Group without any treatment

100 patients don't receive any blockade therapies

No interventions assigned to this group

Interventions

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Tenofovir1

receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.

Intervention Type DRUG

Tenofovir2

receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.

Intervention Type DRUG

Tenofovir3

receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.

Intervention Type DRUG

Tenofovir4

receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy patients with HBeAg-negative or HBV-DNA\<106copies /ml
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guiqin Bai, M.D.;Ph.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guiqin Bai, M.D.;Ph.D.

Role: CONTACT

Phone: 86-18991232517

Email: [email protected]

Facility Contacts

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Guiqin Bai, M.D.;Ph.D.

Role: primary

References

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Gao F, Zhang WT, Lin YY, Wang WM, Xu N, Bai GQ. Early Start Of Tenofovir Treatment Achieves Better Viral Suppression In Pregnant Women With A High HBV Viral Load: A Real-World Prospective Study. Infect Drug Resist. 2019 Nov 7;12:3475-3484. doi: 10.2147/IDR.S228982. eCollection 2019.

Reference Type DERIVED
PMID: 31807036 (View on PubMed)

Other Identifiers

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XJTU1AHCR2014-018

Identifier Type: -

Identifier Source: org_study_id