Clinical trial NCT06947356: Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis B
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 210
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: see summary

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.

Primary outcomes:
measure: The mother-to-child transmission rate of HBV
timeFrame: 28 weeks
Secondary outcomes:
measure: Congenital defects/malformations in infants
timeFrame: 28 weeks
measure: The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL
timeFrame: 12 weeks
measure: The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion
timeFrame: 36 weeks
measure: ALT levels during or after TDF/TAF treatment
timeFrame: 36 weeks
measure: Renal function parameters of pregnant women
timeFrame: 36 weeks
measure: Adverse events (including obstetric complications and laboratory abnormalities)
timeFrame: 36 weeks
measure: Proportion of two groups that discontinued treatment due to adverse events
timeFrame: 36 weeks
measure: Health-related quality of life (HRQoL) indicators of pregnant women
timeFrame: 36 weeks
measure: Health-related quality of life (HRQoL) indicators of pregnant women
timeFrame: 36 weeks
measure: Health-related quality of life (HRQoL) indicators of pregnant women
timeFrame: 36 weeks
Other outcomes:
measure: HBV DNA levels below 20 IU/mL
timeFrame: 12 weeks
measure: Placental abnormalities
timeFrame: 12 weeks
measure: Change in bone mineral density
timeFrame: 36 weeks
measure: Depression, MASLD, or liver fibrosis
timeFrame: 36 weeks
Locations:
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital, Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Baoan Women's and Children's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Shijiazhuang Maternity & Child Healthcare Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Fifth Hospital of Shijiazhuang
state: Hebei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Beijing You 'an Hospital, Capital Medical University
Study officials:
References: