TAF in Early/Middle Pregnancy With CHB (TAF;CHB)

Efficacy and Safety of TAF Used in Early and Middle Pregnancy With Chronic Hepatitis B: a Multicenter Prospective Cohort Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnant Women; Hepatitis B Infection; Early Pregnancy
• Intervention / Treatment: Drug: TAF; Drug: TDF

Detailed Description

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. Previous studies have found that TAF has good clinical efficacy in the treatment of antiviral therapy in patients with chronic hepatitis B. In order to evaluate the clinical efficacy of TAF after antiviral therapy in pregnant women with chronic hepatitis B in the first and second trimesters, the clinical efficacy of TAF after antiviral therapy was evaluated by comparing the safety (including changes in maternal ALT, bilirubin, creatinine, blood phosphorus, blood lipids, fetal malformation rate, neonatal birth defects, head circumference, height, weight, intelligence and other indicators) and effectiveness (viral load decrease, serological conversion, mother-to-fetal blockade, etc.) with the TDF group.

• Study Type: Interventional
• Enrollment (Estimated): 816
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between the ages of 20 and 40
• HBsAg positive for >= 6 months
• 0-24 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tenofovir alafenamide; An oral drug for reducing hepatitis B virus levels.	Drug: TAF; Taking TAF from early or middle pregnancy; Other Names: tenofovir alafenamide
Active Comparator: tenofovir disoproxil fumarate; An oral drug for reducing hepatitis B virus levels.	Drug: TDF; Taking TDF from early or middle pregnancy; Other Names: tenofovir disoproxil fumarate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the level of HBV-DNA of baby	At birth; At 7 months of age	not more than 7 months
To assess the level of HBV-DNA of mother	Every 4 weeks of pregnancy	not more than 48 weeks
To assess the results of liver Ultrasound of mother	At the time of enrollment; During childbirth	not more than 48 weeks
To assess the weight in kilograms of baby	At birth; At 7 months of age	not more than 7 months
To assess the height in meters of baby	At birth; At 7 months of age	not more than 7 months
The number of HBsAg positive of baby	At birth; At 7 months of age	not more than 7 months
The number of HBeAg positive of baby	At birth; At 7 months of age	not more than 7 months
The number of HBsAg positive of mother	Every 4 weeks of pregnancy	not more than 48 weeks
The number of HBeAg positive of mother	Every 4 weeks of pregnancy	not more than 48 weeks
The rate of deformity	Fetal period	not more than 48 weeks
The rate of Birth defect	At birth	1 day
The levels of creatinine of mother	From the time of initiation of antiviral until delivery	not more than 48 weeks
The levels of blood lipids of mother	From the time of initiation of antiviral until delivery	not more than 48 weeks

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Guangzhou Medical University
• Collaborators: Second Affiliated Hospital of Guangzhou Medical University; Qingyuan People's Hospital
• Investigators: Principal Investigator: Panpan Zhai, The Third Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis; Hepatitis B; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Purines; Organophosphorus Compounds; Organophosphonates; Adenine; Tenofovir; tenofovir alafenamide
• Other Study ID Numbers: [2025]004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No