Study of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus
NCT ID: NCT04065230
Last Updated: 2019-08-22
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
330 participants
OBSERVATIONAL
2019-08-31
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TAF antiviral therapy group
Tenofovir Alafenamide Fumarate tablets
Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.
Interventions
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Tenofovir Alafenamide Fumarate tablets
Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.
Eligibility Criteria
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Inclusion Criteria
* 20-24 week of gestation
* HBsAg-positive more than 6 months and HBeAg-positive
* HBV DNA\> 1000,000 IU/ml
* both husband and wife voluntarily sign informed consent
* with good compliance and comply with follow-up programs
Exclusion Criteria
* evidence of decompensated liver disease
* combined with important organ lesions which will affect patient compliance and follow-up plans, pregnant women who are expected to be difficult to complete the study
* have a history of spontaneous abortion, or have a birth defect or congenital malformation in the last pregnancy
* mother treated with antiviral therapy within 6 months prior to enrollment(except those treated with antiviral therapy in the last pregnancy to prevent mother-to-child transmission)
* have a history of kidney injury, creatinine clearance \<50ml/min, urine protein positive (\>300mg/L)
* combined with other chronic diseases and need to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy
* the infants' biologic father is a chronic HBV infected person
* symptoms of threatened abortion during early pregnancy
* evidence of hepatic cell carcinoma
* alanine aminotransferase (ALT) \> 10 x upper limit of normal(ULN ), or total bilirubin (TBIL) \> 3 x ULN or glomerular filtration rate (GFR) \< 90 mL (min\*1.73 m2), or serum Albumin (ALB) \< 25 g/L before enrollment
* fetal malformations detected by B-ultrasound
* participants in other research
20 Years
35 Years
FEMALE
No
Sponsors
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Southeast University, China
OTHER
Responsible Party
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Guo-rong Han
Director of Obstetrics and Gynecology
Locations
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The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Han G, Zhou G, Sun T, Luo X, Xu J, Chen C, Xu W, Jiang S, Wang C. Tenofovir alafenamide in blocking mother-to-child transmission of hepatitis B virus: a multi-center, prospective study. J Matern Fetal Neonatal Med. 2022 Dec;35(26):10551-10558. doi: 10.1080/14767058.2022.2134771. Epub 2022 Oct 17.
Other Identifiers
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H201908
Identifier Type: -
Identifier Source: org_study_id
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