NCT07542951

Brief Summary

The goal of this clinical trial is to learn the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy antiviral therapy for chronic hepatitis B pregnant women. The main questions it aims to answer are: The rate of HBV mother-to-child transmission between the TAF and TDF groups. The incidence of birth defects in newborns between the TAF and TDF groups. What medical problems do participants have when taking drug TAF or TDF? The growth and development indices of newborns between the TAF and TDF groups. Participants will: Take drug TAF or TDF every day during the pregnacy. Visit the clinic once every 4 weeks for checkups and tests during the pregnancy and every 12 weeks postpartum.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
43mo left

Started Dec 2024

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Dec 2024Dec 2029

Study Start

First participant enrolled

December 27, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

April 9, 2026

Last Update Submit

April 17, 2026

Conditions

Hepatitis B Virus Infection; Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • Hepatitis B virus Mother-to-infant blocking rate

    test HBsAg and HBV-DNA of the infants

    participant' infants 7 months old

Secondary Outcomes (2)

  • Rate of birth defects

    When participants gave birth

  • Incidence of complications and adverse drug reactions during pregnancy

    From date of randomization until the date of first documented progression, assessed up to 14 months

Other Outcomes (1)

  • Neonatal growth and development index

    From birth to 3 years old

Study Arms (2)

TDF

ACTIVE COMPARATOR
Drug: TAF

TAF

EXPERIMENTAL
Drug: TAF

Interventions

TAFDRUG

Taking TAF during the pregnancy

TAFTDF

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female gender. Age between 20-40 years old. Positive for HBsAg for ≥6 months. Pregnant at 0-24 weeks meeting the 2022 China Chronic Hepatitis B guidelines for antiviral therapy (including but not elevated transaminases, liver cirrhosis, hepatic fibrosis, or extrahepatic manifestations of hepatitis B).
  • Willingness to take TAF/TDF orally once daily from enrollment until delivery or long-term use.
  • Good medication compliance.

You may not qualify if:

  • Co-infection with hepatitis A, C, E viruses, other hepatotropic viruses, or HIV.
  • Liver cirrhosis, liver cancer, or other chronic liver diseases. Significant organ diseases (e.g., heart, lung, or kidney diseases). Autoimmune hepatitis, autoimmune diseases, hypertension, diabetes, or thyroid disorders.
  • History of pregnancy complications. History of fetal/neonatal growth defects in previous pregnancies. Use of nephrotoxic drugs, corticosteroids, NSAIDs, cytotoxic drugs, or immunomodulators prior to enrollment.
  • Abnormal ultrasound findings indicating fetal malformations, placental abnormalities, or threatened miscarriage before treatment initiation.
  • Failure to attend follow-up visits as scheduled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Diseases, Guangdong Provincial Key Laboratory of Major Obstetric Diseases; Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University,

Guangzhou, Guangdong, 450000, China

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 21, 2026

Study Start

December 27, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

CN(1)