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Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)

NCT05177926 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2022-01-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.

Conditions

  • Hepatitis B, Chronic
  • Mother to Child Transmission

Interventions

DRUG

antiviral prophylaxis with Tenofovir Alafenamide Fumarate

All participants will receive antiviral prophylaxis with Tenofovir Alafenamide Fumarate for preventing of Mother-to-child transmission of HBV

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Jinlin Hou · Nanfang Hospital, Southern Medical University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-04
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05177926 on ClinicalTrials.gov