NCT06947356 Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
| NCT ID | NCT06947356 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou 8th People's Hospital |
| Condition | Hepatitis B |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-05-03 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2025-05-03 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and those receiving treatment with tenofovir disoproxil fumarate, after administering the hepatitis B vaccine and hepatitis B immunoglobulin to their infants at birth. Investigators define the mother-to-infant transmission rate of hepatitis B as the proportion of infants who are HBsAg positive and have serum HBV DNA \>20 IU/mL at 28 weeks of age among all live births in the experimental group. Additionally, this study will also compare the incidence of congenital defects/malformations in infants born to mothers treated with tenofovir alafenamide and tenofovir disoproxil fumarate during the perinatal period to assess drug safety.
Eligibility Criteria
Inclusion Criteria: 1. Pregnant women aged between 20 and 40 years old 2. Pregnancy duration between 20 to 28 weeks (screening for eligible patients can start from the 20th week of gestation) 3. Clinically diagnosed with compensated chronic hepatitis B, HBsAg positive for more than 6 months, with clinical history, signs, and test results consistent with compensated chronic hepatitis B 4. HBsAg and HBeAg positive in maternal serum during screening 5. PCR testing shows maternal serum HBV DNA levels exceeding 200,000 IU/mL 6. Subjects voluntarily agree to undergo treatment according to the study design's drug treatment plan and all other research requirements, and patients consent to strictly avoid pregnancy within 28 weeks postpartum 7. Patients and their husbands (the biological parents of the child) understand the risks and voluntarily participate in the study. The mother must participate voluntarily and sign a written informed consent document before participating in the study. Exclusion Criteria: 1. Creatinine clearance \< 100 mL/min (calculated using the Cockcroft-Gault method based on serum creatinine and ideal body weight), or hypophosphatemia (below normal range). 2. History of adverse renal reactions induced by Adefovir or history of Adefovir resistance. 3. Meeting one of the following criteria: hemoglobin \< 80 g/L, neutrophil count \< 1000/μL, ALT \> 5 times the upper limit of normal, total bilirubin \> 20 mg/L, albumin \< 25 g/L, abnormal levels of creatinine or urea nitrogen. 4. Pregnant women with a history of miscarriage, history of giving birth to a child with congenital malformations, or history of fetal infection with hepatitis B virus. 5. The biological father of the current pregnancy has chronic hepatitis B. 6. The investigator assesses that the subject has significant kidney, cardiovascular, pulmonary, or neurological diseases that affect their participation in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06947356 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06947356 currently recruiting?
Yes, NCT06947356 is actively recruiting participants. Contact the research team at Panc01@nyu.edu for enrollment information.
Where is the NCT06947356 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guangzhou, China, Guangzhou, China and 6 additional locations.
Who is sponsoring the NCT06947356 clinical trial?
NCT06947356 is sponsored by Guangzhou 8th People's Hospital. The trial plans to enroll 210 participants.