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NCT02719808

A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection

Status unknown Last updated 16 November 2020
What this trial tests

trial testing Tenofovir1 in Hepatitis B, Chronic in 500 participants. Status unknown.

Timeline
1 March 2015
Primary endpoint
1 December 2022
1 December 2022

Quick facts

Lead sponsorFirst Affiliated Hospital Xi'an Jiaotong University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment500
Start date1 March 2015
Primary completion1 December 2022
Estimated completion1 December 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Who can join

Eligibility, female only, with Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy of tenofovir in preventing perinatal transmission of HBV infection in pregnant women with high viral loads.
    Lin Y, Liu Y, Ding G, Touqui L, et al · · 2018 · cited 28× · PMID 30341345 · DOI 10.1038/s41598-018-33833-w
  2. Early Start Of Tenofovir Treatment Achieves Better Viral Suppression In Pregnant Women With A High HBV Viral Load: A Real-World Prospective Study.
    Gao F, Zhang WT, Lin YY, Wang WM, et al · · 2019 · cited 8× · PMID 31807036 · DOI 10.2147/idr.s228982

Verify or expand the search:

Other recruiting trials for Hepatitis B, Chronic

Currently open trials in the same condition.

Other First Affiliated Hospital Xi'an Jiaotong University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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