RecruitingChronic Hepatitis bTenofovir Alafenamide Fumarate
Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women
Eligible age
20–40 yrs
Accepts
Women
Locations
0 states
Healthy volunteers
No
See if you qualify for this study
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About this study
The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.
Sponsor: First People's Hospital of Hangzhou
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Source: ClinicalTrials.gov · NCT05853718 · last updated 2025-09-08