Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
A Multicenter, Prospective, Open-label, Non-inferiority Randomized Controlled Study on the Efficacy of Tenofovir Alafenamide Fumarate vs. Tenofovir Disoproxil Fumarate in Preventing Mother-to-Child Transmission of Hepatitis B Virus in Pregnant Women With High Viral Loads
1 other identifier
interventional
210
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2025
CompletedFirst Posted
Study publicly available on registry
April 27, 2025
CompletedStudy Start
First participant enrolled
May 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
May 7, 2025
May 1, 2025
3 years
April 20, 2025
May 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The mother-to-child transmission rate of HBV
Compare the difference in HBV mother-to-infant transmission rates between pregnant women receiving TAF treatment and vaccinating their infants with hepatitis B vaccine and HBIg, and those receiving TDF treatment with the same vaccination for their infants. Here, the mother-to-infant transmission rate is defined as the proportion of infants in the experimental group who have serum HBV DNA \>20 IU/mL and are HBsAg positive at 28 weeks of age among all live births.
28 weeks
Secondary Outcomes (10)
Congenital defects/malformations in infants
28 weeks
The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL
12 weeks
The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion
36 weeks
ALT levels during or after TDF/TAF treatment
36 weeks
Renal function parameters of pregnant women
36 weeks
- +5 more secondary outcomes
Other Outcomes (4)
HBV DNA levels below 20 IU/mL
12 weeks
Placental abnormalities
12 weeks
Change in bone mineral density
36 weeks
- +1 more other outcomes
Study Arms (2)
TAF group
EXPERIMENTALPregnant women will start TAF treatment (25 mg tablet taken orally once daily) from 28 weeks of gestation until delivery. After that, they will be randomly assigned to two subgroups among postpartum mothers without HBV treatment indications: one subgroup will stop treatment, while the other subgroup will continue with an additional 12 weeks of TAF treatment. The mothers and their infants will be followed up at 28 weeks postpartum. Infants will receive the hepatitis B vaccine and HBIG within 12 hours after birth, as well as booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
TDF group
ACTIVE COMPARATORThe mother will start receiving TDF treatment (300 mg tablet taken orally once daily) at 28 weeks of pregnancy until delivery. After that, mothers without HBV treatment indications will be randomly assigned to two subgroups: one subgroup will stop treatment, while the other subgroup will receive an additional 12 weeks of TDF treatment. Infants will be vaccinated with the hepatitis B vaccine and HBIG within 12 hours after birth, as well as receive booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
Interventions
Pregnant women will start TAF treatment (25 mg tablet taken orally once daily) from 28 weeks of gestation until delivery. After that, they will be randomly assigned to two subgroups among postpartum mothers without treatment indications: one subgroup will stop treatment, while the other subgroup will continue with an additional 12 weeks of TAF treatment. The mothers and their infants will be followed up at 28 weeks postpartum. Infants will receive the hepatitis B vaccine and HBIG within 12 hours after birth, as well as booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
The mother will start receiving TDF treatment (300 mg tablet taken orally once daily) at 28 weeks of pregnancy until delivery. After that, mothers without treatment indications will be randomly assigned to two subgroups: one subgroup will stop treatment, while the other subgroup will receive an additional 12 weeks of TDF treatment. Infants will be vaccinated with the hepatitis B vaccine and HBIG within 12 hours after birth, as well as receive booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
April 20, 2025
First Posted
April 27, 2025
Study Start
May 3, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
May 7, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
The investigators are committed to the responsible sharing of anonymized Individual Patient Data (IPD) with qualified external researchers upon request or as required by law and/or regulation, based on the following criteria: 1. Nature of the Request: The specific details and objectives of the data request will be reviewed to ensure alignment with ethical standards and research integrity. 2. Merit of the Proposed Research: The proposed research's potential scientific value and contribution to the broader scientific community will be evaluated. Priority will be given to research that addresses significant clinical or scientific questions. 3. Availability of the Data: The feasibility of sharing the requested data, considering any technical, legal, or logistical constraints, will be assessed. 4. Intended Use of the Data: The intended use of the data will be scrutinized to ensure it is appropriate