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Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women

RECRUITINGPhase 4Sponsored by First People's Hospital of Hangzhou
Actively Recruiting
PhasePhase 4
SponsorFirst People's Hospital of Hangzhou
Started2021-05-06
Est. completion2025-12-30
Eligibility
Age20 Years – 40 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05853718

Summary

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

Eligibility

Age: 20 Years – 40 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions3

Chronic Hepatitis bLiver DiseaseTenofovir Alafenamide Fumarate

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