NCT07668934

Brief Summary

The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
816

participants targeted

Target at P75+ for phase_4

Timeline
21mo left

Started Mar 2025

Typical duration 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 Progress45%
Mar 2025Mar 2028

Study Start

First participant enrolled

March 31, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

June 25, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

April 9, 2026

Last Update Submit

June 21, 2026

Conditions

Hepatitis B InfectionPregnant WomenEarly Pregnancy

Outcome Measures

Primary Outcomes (1)

  • To assess the incidence of ALT above normal (>=1 time) of mother

    From the time of initiation of antiviral and normal ALT until delivery

    not more than 48 weeks

Secondary Outcomes (13)

  • To assess the level of HBV-DNA of baby

    not more than 7 months

  • To assess the level of HBV-DNA of mother

    not more than 48 weeks

  • To assess the results of liver Ultrasound of mother

    not more than 48 weeks

  • To assess the weight in kilograms of baby

    not more than 7 months

  • To assess the height in meters of baby

    not more than 7 months

  • +8 more secondary outcomes

Study Arms (2)

tenofovir alafenamide

EXPERIMENTAL

An oral drug for reducing hepatitis B virus levels.

Drug: TAF

tenofovir disoproxil fumarate

ACTIVE COMPARATOR

An oral drug for reducing hepatitis B virus levels.

Drug: TDF

Interventions

TAFDRUG

Taking TAF from early or middle pregnancy

Also known as: tenofovir alafenamide
tenofovir alafenamide
TDFDRUG

Taking TDF from early or middle pregnancy

Also known as: tenofovir disoproxil fumarate
tenofovir disoproxil fumarate

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 20 and 40
  • HBsAg positive for \>= 6 months
  • week of pregnancy
  • Meets the indications for antiviral therapy in the 2022 version of the guidelines for the prevention and treatment of chronic hepatitis B
  • It is planned to use TAF or TDF antiviral therapy until the end of delivery or long-term administration, and follow-up will be carried out in this research institution
  • Signed informed consent for medication

You may not qualify if:

  • Previous use of anti-hepatitis B virus drugs (e.g., entecavir, tenofovir, tenofovir alafenol, emintenofovir, adefovir dipoproxil, telbivudine, etc.)
  • Concomitant viral hepatitis A, C, E or other hepatotropic virus infection or AIDS
  • Concomitant cirrhosis, liver cancer or other chronic liver diseases (e.g., alcoholic liver, autoimmune liver disease, G6PD deficiency, etc.)
  • Patients with heart (such as coronary heart disease, myocardial infarction, heart failure, etc.), lung (such as: lung cancer, chronic obstructive pulmonary disease, tuberculosis, etc.), kidney (such as: renal failure, elevated creatinine, nephritis, nephrotic syndrome, etc.) and other important organ diseases
  • Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, etc
  • Patients with previous pregnancy complications (such as: gestational hypertension, gestational diabetes, gestational eclampsia, etc.)
  • Those who have had fetal or neonatal growth and development defects in previous pregnancies
  • Previous or ongoing use of nephrotoxic medications, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators
  • Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, threatened abortion, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

tenofovir alafenamideTenofovir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Panpan Zhai

    The Third Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

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

June 25, 2026

Study Start

March 31, 2025

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

June 25, 2026

Record last verified: 2026-05

Locations

CN(1)