Menu
Enrolling by invitation NCT07668934

TAF in Early/Middle Pregnancy With CHB

Phase IV Interventional Hepatitis B Infection Pregnant Women Early Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TAF, TDF.
Who it may be relevant to
Registry conditions: Hepatitis B Infection, Pregnant Women, Early Pregnancy. Basic parameters: 20 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Drug TAF
    Taking TAF from early or middle pregnancy
  • Drug TDF
    Taking TDF from early or middle pregnancy

Primary outcome measures

  • To assess the incidence of ALT above normal (>=1 time) of mother [Time frame: not more than 48 weeks]
Secondary outcome measures (12)
  • To assess the level of HBV-DNA of baby [Time frame: not more than 7 months]
  • To assess the level of HBV-DNA of mother [Time frame: not more than 48 weeks]
  • To assess the results of liver Ultrasound of mother [Time frame: not more than 48 weeks]
  • To assess the weight in kilograms of baby [Time frame: not more than 7 months]
  • To assess the height in meters of baby [Time frame: not more than 7 months]
  • The number of HBsAg positive of baby [Time frame: not more than 7 months]
  • The number of HBeAg positive of baby [Time frame: not more than 7 months]
  • The number of HBsAg positive of mother [Time frame: not more than 48 weeks]
  • The number of HBeAg positive of mother [Time frame: not more than 48 weeks]
  • The rate of deformity [Time frame: not more than 48 weeks]
  • The rate of Birth defect [Time frame: 1 day]
  • The levels of creatinine of mother [Time frame: not more than 48 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT07668934 · [2025]004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗