Actively Recruiting
Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
Led by Guangzhou 8th People's Hospital · Updated on 2025-05-07
210
Participants Needed
10
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged between 20 and 40 years old
- Pregnancy duration between 20 to 28 weeks
- Diagnosed with compensated chronic hepatitis B, HBsAg positive for over 6 months
- Positive HBsAg and HBeAg in maternal serum at screening
- Maternal serum HBV DNA levels above 200,000 IU/mL by PCR test
- Agree to treatment per study plan and avoid pregnancy for 28 weeks postpartum
- Mothers and their husbands understand risks and consent to participate with signed informed consent
You will not qualify if you...
- Creatinine clearance below 100 mL/min or low phosphate levels
- History of adverse kidney reactions or resistance to Adefovir
- Hemoglobin under 80 g/L, neutrophils below 1000/µL, ALT over 5 times normal, total bilirubin over 20 mg/L, albumin under 25 g/L, or abnormal creatinine or urea nitrogen
- History of miscarriage, birth defects, or fetal hepatitis B infection
- Biological father has chronic hepatitis B
- Significant kidney, heart, lung, or neurological diseases affecting study participation
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
2
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Not Yet Recruiting
3
The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou
Guangzhou, Guangdong, China
Not Yet Recruiting
4
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
5
Shenzhen Baoan Women's and Children's Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
6
Shijiazhuang Maternity & Child Healthcare Hospital
Shijiazhuang, Hebei, China
Not Yet Recruiting
7
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
Not Yet Recruiting
8
Xiangya Hospital, Central South University
Changsha, Hunan, China
Not Yet Recruiting
9
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Not Yet Recruiting
10
Beijing You 'an Hospital, Capital Medical University
Beijing, China
Not Yet Recruiting
Research Team
C
Calvin.Q Pan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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