Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First People's Hospital of Hangzhou
• Treatments: Tenofovir

Criteria

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.