Actively Recruiting
Comparison of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate to Prevent Mother-to-Child Transmission of Hepatitis B in Pregnant Women With High Viral Loads
Led by Guangzhou 8th People's Hospital · Updated on 2025-05-07
210
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare how well two treatments, tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF), prevent mother-to-infant transmission of hepatitis B in pregnant women with high viral loads. The study will measure the rate of hepatitis B transmission to infants by checking if infants are positive for hepatitis B surface antigen and have significant viral levels at 28 weeks of age. It will also assess the safety of both treatments by comparing the rates of birth defects in babies born to mothers who received either drug during pregnancy. Pregnant women will start either TAF (25 mg daily) or TDF (300 mg daily) from 28 weeks of pregnancy until delivery. After birth, mothers without further treatment indications will be randomly assigned to either stop treatment or continue the assigned drug for an additional 12 weeks. All infants will receive the hepatitis B vaccine and hepatitis B immunoglobulin (HBIG) within 12 hours after birth, plus booster vaccine doses at 4 and 24 weeks. The study includes follow-up of mothers and infants until 28 weeks postpartum. Participants will be closely monitored through clinical visits and testing during pregnancy and postpartum. Researchers will measure hepatitis B transmission rates, birth defect incidence, viral load levels, liver enzymes, kidney function, adverse events, and mothers' quality of life up to 36 weeks. The study lasts from the start of treatment at 28 weeks gestation through 28 weeks after birth, with detailed assessments during and after treatment to understand treatment effects and safety.
CONDITIONS
Brief 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 more than 6 months
- Positive for HBsAg and HBeAg in maternal serum during screening
- Maternal serum HBV DNA levels exceeding 200,000 IU/mL
- Agree to undergo treatment according to the study drug plan and avoid pregnancy within 28 weeks postpartum
- Mother and her husband understand risks and voluntarily participate with signed informed consent
You will not qualify if you...
- Creatinine clearance less than 100 mL/min or low phosphate levels
- History of adverse kidney reactions to Adefovir or Adefovir resistance
- Severe blood or liver abnormalities including low hemoglobin, low neutrophils, very high ALT, high bilirubin, low albumin, or abnormal creatinine/urea nitrogen
- History of miscarriage, child with birth defects, or fetal hepatitis B infection
- Biological father of current pregnancy has chronic hepatitis B
- Significant kidney, heart, lung, or neurological diseases affecting study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 28 weeks of pregnancy until delivery plus up to 12 additional weeks postpartum for some participants
Participants receive daily oral TAF or TDF treatment starting from 28 weeks of pregnancy until delivery. After delivery, mothers without treatment indications are randomly assigned to either stop treatment or continue with an additional 12 weeks of the assigned drug.
Weekly visits from 28 weeks of pregnancy until delivery and additional visits during the 12-week postpartum treatment period if applicable
Duration - Up to 28 weeks postpartum
Mothers and their infants are followed up to 28 weeks postpartum to monitor health outcomes and vaccination effects.
Approximately 3 visits postpartum including infant vaccination visits at birth, 4 weeks, and 24 weeks
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here