Comparing two treatments to prevent hepatitis B transmission from mothers to infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of two antiviral treatments, tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF), in preventing the transmission of hepatitis B from pregnant women with high viral loads to their infants. Pregnant women aged 20 to 40 years, diagnosed with compensated chronic hepatitis B and having high levels of HBV DNA, will be enrolled. The study will measure the rate of mother-to-infant transmission of hepatitis B and assess the safety of the treatments by monitoring congenital defects in infants. Infants will receive the hepatitis B vaccine and immunoglobulin at birth as part of the prevention strategy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangzhou Eighth People's Hospital, Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Guangzhou Women and Children's Medical Center
  Guangzhou, Guangdong, China Not yet recruiting
• The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou
  Guangzhou, Guangdong, China Not yet recruiting
• The Third Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• Shenzhen Baoan Women's and Children's Hospital
  Shenzhen, Guangdong, China Not yet recruiting
• Shijiazhuang Maternity & Child Healthcare Hospital
  Shijiazhuang, Hebei, China Not yet recruiting

Study contacts

• Study coordinator: Calvin.Q Pan
• Email: Panc01@nyu.edu
• Phone: +86 13632293277

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.