Status:
RECRUITING
Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
Lead Sponsor:
Guangzhou 8th People's Hospital
Conditions:
Hepatitis B
Eligibility:
FEMALE
20-40 years
Phase:
NA
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 treatmen...
Detailed Description
see summary
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06947356
Start Date
May 3 2025
End Date
May 1 2028
Last Update
May 7 2025
Active Locations (10)
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1
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
2
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
3
The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou
Guangzhou, Guangdong, China
4
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China