Actively Recruiting

Phase 4
Age: 20Years - 40Years
FEMALE
NCT05853718

Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women

Led by First People's Hospital of Hangzhou · Updated on 2025-09-08

50

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women

Who Can Participate

Age: 20Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age of 20-40 years
  • Positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg)
  • HBV DNA level greater than 200,000 IU/mL during pregnancy weeks 24 to 32
  • Willing to take Tenofovir Alafenamide for preventing mother-to-child transmission
  • Both participant and spouse willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Co-infection with hepatitis C, HIV, or other chronic diseases
  • History of spontaneous abortion or congenital malformation
  • Decompensated cirrhosis or liver cancer
  • History of kidney injury, creatinine clearance less than 50 ml/min, or urine protein test positive (>300 mg/L)
  • Fetal malformations detected by ultrasound during pregnancy
  • Alanine aminotransferase (ALT) levels more than twice the upper limit of normal
  • Total bilirubin (TBIL) greater than or equal to the upper limit of normal
  • Albumin (ALB) less than 25 g/L

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

J

Jie Jin, MD

CONTACT

Z

Zhiyuan Ma, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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