Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads

Recruiting now · Not applicable

Conditions studied: Hepatitis B

In brief

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.

Key facts

Study ID: NCT06947356
Run by: Guangzhou 8th People's Hospital
People needed: 210
Starts: 2025-05-03
Expected to finish: 2028-05-01
Last updated by the study team: 2025-05-07

Who can join

Age: 20 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Pregnant women aged between 20 and 40 years old
Pregnancy duration between 20 to 28 weeks (screening for eligible patients can start from the 20th week of gestation)
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
HBsAg and HBeAg positive in maternal serum during screening
PCR testing shows maternal serum HBV DNA levels exceeding 200,000 IU/mL
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
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.

You may not qualify if…

Creatinine clearance < 100 mL/min (calculated using the Cockcroft-Gault method based on serum creatinine and ideal body weight), or hypophosphatemia (below normal range).
History of adverse renal reactions induced by Adefovir or history of Adefovir resistance.
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.
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.
The biological father of the current pregnancy has chronic hepatitis B.
The investigator assesses that the subject has significant kidney, cardiovascular, pulmonary, or neurological diseases that affect their participation in the study.

Where it is running

Guangzhou Eighth People's Hospital, Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou — Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
Shenzhen Baoan Women's and Children's Hospital — Shenzhen, Guangdong, China
Shijiazhuang Maternity & Child Healthcare Hospital — Shijiazhuang, Hebei, China
The Fifth Hospital of Shijiazhuang — Shijiazhuang, Hebei, China
Xiangya Hospital, Central South University — Changsha, Hunan, China
The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
Beijing You 'an Hospital, Capital Medical University — Beijing, China

Full record on ClinicalTrials.gov

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