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Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women

RecruitingPhase 4Ages 20 Years - 40 YearsFemaleFirst People's Hospital of Hangzhou
NCT05853718 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age of 20-40 years; Positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg); HBV DNA level \>200 000 IU/mL during the 24th-32nd week of pregnancy; Willing to take TAF for mother-to-child blockade; Both husband and wife are willingly sign an informed consent. Exclusion Criteria: * Co-infected with hepatitis C or HIV, or other chronic diseases; History of spontaneous abortion or congenital malformation; Decompensated cirrhosis and liver cancer; History of kidney injury, CCr \<50ml/min and urine protein test positive (\>300mg/L); Fetal malformations detected by B-ultrasound during pregnancy; ALT \> 2×upper limit of normal (ULN); TBIL ≥ 1×ULN; Albumin (ALB) \< 25 g/L.
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What it tests

  • Tenofovir Alafenamide Tablets
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Where

1 site
Hangzhou First People's Hospital
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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