Optimal Time for Tenofovir Treatment of Anti-Hepatitis B Virus (HBV) During the Pregnancy
NCT ID: NCT02510963
Last Updated: 2016-08-10
Study Results
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2015-11-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tenofovir 24 week
Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 24 weeks of gestation to 1 month postpartum
Tenofovir Disoproxil Fumarate
Use Tenofovir at 24week of gestation
Tenofovir 28 week
Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 28 weeks of gestation to 1 month postpartum
Tenofovir Disoproxil Fumarate
Use Tenofovir at 28week of gestation
Tenofovir 32 week
Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 32 weeks of gestation to 1 month postpartum
Tenofovir Disoproxil Fumarate
Use Tenofovir at 32week of gestation
Interventions
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Tenofovir Disoproxil Fumarate
Use Tenofovir at 24week of gestation
Tenofovir Disoproxil Fumarate
Use Tenofovir at 28week of gestation
Tenofovir Disoproxil Fumarate
Use Tenofovir at 32week of gestation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have had HBsAg positive in serum greater than 6 months
* HBV DNA load\>10\*\*6 IU/ml
* Gestation week\<24 weeks
* Normal liver function
* Able to comprehend and willing to sign the informed consent form
Exclusion Criteria
* Got antiviral treatments before 24 weeks of Gestation
* Got immunosuppressor treatment and/or steroids
* Got diagnosis of cirrhosis,hepatocellular carcinoma or severe hepatitis B
* Got serious obstetric complications
* Got evidence of fetal deformity diagnosed by four-dimensional color Doppler ultrasound examination
* Biological father of infant had HBV infection
20 Years
40 Years
FEMALE
No
Sponsors
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First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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Tianyan Chen, MD,PHD
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, , China
Countries
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Central Contacts
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Facility Contacts
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Tianyan Chen
Role: primary
Other Identifiers
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XJTU1AHCR2014-013
Identifier Type: -
Identifier Source: org_study_id
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