Status:
UNKNOWN
Study of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus
Lead Sponsor:
Southeast University, China
Conditions:
Hepatitis B Virus
Mother to Child Transmission
Eligibility:
FEMALE
20-35 years
Brief Summary
This study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of TAF in blocking mother-to-child transmission of hepatitis B virus.Pregnant women...
Eligibility Criteria
Inclusion
- maternal age: 20 to 35 years
- 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
- mother with co-infection of hepatitis C virus,human immunodeficiency virus
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04065230
Start Date
August 1 2019
End Date
August 1 2021
Last Update
August 22 2019
Active Locations (1)
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1
The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)
Nanjing, Jiangsu, China, 210003