NCT07668934Enrolling by invitationPhase 4
TAF in Early/Middle Pregnancy With CHB
Efficacy and Safety of TAF Used in Early and Middle Pregnancy With Chronic Hepatitis B: a Multicenter Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 816 (estimated)
- First submitted
- 9 Apr 2026
- Start date
- 31 Mar 2025
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
- Diseases
- Hepatitis B
- NCT number
- NCT07668934
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 816
- From 31 Mar 2025 to the primary completion date, 30 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, etc
Lab values
- 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
Other
- Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, threatened abortion, etc
Who the study is looking for
- 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
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.