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Enrolling by invitationPhase 4

Tenofovir alafenamide compared with tenofovir disoproxil in pregnant women with hepatitis B

Compares two hepatitis B drugs in pregnant women with chronic hepatitis B.

Plain-language title generated from the registry record
Registry title: TAF in Early/Middle Pregnancy With CHB

Key facts

Where
Guangzhou, ChinaSee the site
Phase
Phase 4

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 20 and 40 years old?

Source: NCT07668934, who can take part

Where in China

  • The Third Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
The Third Affiliated Hospital of Guangzhou Medical University
Trial code
NCT07668934
Record updated
25 June 2026
Original 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.Read full original descriptionShow less

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.

Inclusion: 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: 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 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; Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, 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; Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, threatened abortion, etc.

ClinicalTrials.gov NCT07668934