Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B

Summary

To investigate the safety and efficacy of tenofovir alafenamide (orally 25 mg per day) treated in inactive chronic hepatitis B virus (HBV)-infected pregnant women with high viral load from the late pregnancy until the delivery date or postpartum 1 month.

Conditions

• Chronic Hepatitis B
• Mother-to-Child Transmission
• Safety
• Efficacy
• Hepatitis B Virus
• Tenofovir Alafenamide Fumarate

Interventions

DRUG

Tenofovir Alafenamide fumarate 25mg Oral Tablet

Tenofovir alafenamide fumarate initiated from the late pregnancy to the delivery date or postpartum month 1.

Sponsors & Collaborators

• National Natural Science Foundation of China

  collaborator OTHER_GOV

• Henan Provincial People's Hospital

  collaborator OTHER

• The Sixth People's Hospital of Zhengzhou

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Luoyang Central Hospital

  collaborator OTHER

• First Affiliated Hospital of Nanyang Medical College

  collaborator OTHER

• Sixth People's Hospital of Kaifeng

  collaborator UNKNOWN

• Luohe Central Hospital

  collaborator UNKNOWN

• Xinyang Central Hospital

  collaborator OTHER

• Yan'an University Affiliated Hospital

  collaborator OTHER

• Nanyang Central Hospital

  collaborator OTHER

• Fifth People's Hospital of Anyang

  collaborator UNKNOWN

• The First Affiliated Hospital of Zhengzhou University

  lead OTHER

Principal Investigators

• Qing-Lei Zeng · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-26

Primary Completion

2022-12-31

Completion

2022-12-31