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Enrolling by Invitation

NCT Number: NCT07668934

TAF in Early/Middle Pregnancy With CHB

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAF

Drug

Taking TAF from early or middle pregnancy

Other names: tenofovir alafenamide

TDF

Drug

Taking TDF from early or middle pregnancy

Other names: tenofovir disoproxil fumarate

Primary outcomes

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

    Time frame: not more than 48 weeks

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

Secondary outcomes

  1. To assess the level of HBV-DNA of baby

    Time frame: not more than 7 months

    At birth; At 7 months of age

  2. To assess the level of HBV-DNA of mother

    Time frame: not more than 48 weeks

    Every 4 weeks of pregnancy

  3. To assess the results of liver Ultrasound of mother

    Time frame: not more than 48 weeks

    At the time of enrollment; During childbirth

  4. To assess the weight in kilograms of baby

    Time frame: not more than 7 months

    At birth; At 7 months of age

  5. To assess the height in meters of baby

    Time frame: not more than 7 months

    At birth; At 7 months of age

  6. The number of HBsAg positive of baby

    Time frame: not more than 7 months

    At birth; At 7 months of age

  7. The number of HBeAg positive of baby

    Time frame: not more than 7 months

    At birth; At 7 months of age

  8. The number of HBsAg positive of mother

    Time frame: not more than 48 weeks

    Every 4 weeks of pregnancy

  9. The number of HBeAg positive of mother

    Time frame: not more than 48 weeks

    Every 4 weeks of pregnancy

  10. The rate of deformity

    Time frame: not more than 48 weeks

    Fetal period

  11. The rate of Birth defect

    Time frame: 1 day

    At birth

  12. The levels of creatinine of mother

    Time frame: not more than 48 weeks

    From the time of initiation of antiviral until delivery

  13. The levels of blood lipids of mother

    Time frame: not more than 48 weeks

    From the time of initiation of antiviral until delivery

Sponsors and collaborators

Lead sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

  • Qingyuan People's Hospital
  • Second Affiliated Hospital of Guangzhou Medical University

Registry information

Official study title

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

Acronym: TAF;CHB

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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