Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women

Last updated: May 8, 2023
Sponsor: First People's Hospital of Hangzhou
Overall Status: Active - Recruiting

Phase

4

Condition

Hepatitis B

Treatment

Tenofovir Alafenamide Tablets

Clinical Study ID

NCT05853718
IIT-20210825-0020-01
  • Ages 20-40
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age of 20-40 years; Positive for hepatitis B surface antigen (HBsAg) and hepatitis Bvirus e antigen (HBeAg); HBV DNA level >200 000 IU/mL during the 24th-32nd week ofpregnancy; Willing to take TAF for mother-to-child blockade; Both husband and wife arewillingly sign an informed consent.

Exclusion

Exclusion Criteria:

  • Co-infected with hepatitis C or HIV, or other chronic diseases; History of spontaneousabortion or congenital malformation; Decompensated cirrhosis and liver cancer; Historyof kidney injury, CCr <50ml/min and urine protein test positive (>300mg/L); Fetalmalformations detected by B-ultrasound during pregnancy; ALT > 2×upper limit of normal (ULN); TBIL ≥ 1×ULN; Albumin (ALB) < 25 g/L.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Tenofovir Alafenamide Tablets
Phase: 4
Study Start date:
May 06, 2021
Estimated Completion Date:
December 30, 2024

Study Description

Pregnant women with high viral load (HBV DNA>2 × 10^5 IU/mL ) are recommended to be given Tenofovir Disoproxil Fumarate(TDF) for mother-to-child blocking of Chronic hepatitis B(CHB) by guidelines. Tenofovir alafenamide (TAF) is a new targeted pro-drug of Tenofovir (TFV) and was approved for use in China in December 2018. Compared with TDF, the therapeutic dose of TAF is small. 25mg TAF can obtain the antiviral effect similar to 300mg TDF, thus reducing the concentration of TFV in the blood.

This is a prospective clinical study, aiming to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women when used for prevention of mother-to-child transmission of hepatitis B virus. 50 HBeAg-positive and HBV DNA levels ≥ 2 × 10^5 IU/mL pregnant women will be enrolled to receive Tenofovir alafenamide (TAF) from week 28-32 of gestation until delivery. According to the mother's wishes, intensive blood samples will be collected to determine the concentration of TAF and TFV in plasma of pregnant women before and after taking TAF, calculate the pharmacokinetic parameters. And the mother's milk is collected every day for 5 days for TAF concentration determination. The primary endpoint was the pharmacokinetic parameters of TAF and TFV, rate of mother-to-child transmission, the congenital malformation rate of infants. The secondary endpoint was the decrease of HBV DNA level at delivery, the clearance and seroconversion rate of HBeAg, postpartum ALT flare, concentration of TAF and TFV in milk,and other adverse events of mothers and infants.

Connect with a study center

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.