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

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

This study is testing whether two different antiviral treatments can help prevent pregnant women with high hepatitis B levels from passing the virus to their babies.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Guangzhou 8th People's Hospital (other)
• Locations: 10 sites (Guangzhou, Guangdong and 9 other locations)
• Trial ID: NCT06947356 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 20 to 40 years with high HBV DNA levels and a diagnosis of compensated chronic hepatitis B.

Not a fit: Patients who are not pregnant or those with low HBV DNA levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the rates of hepatitis B transmission from mothers to their infants, improving health outcomes for newborns.

How similar studies have performed: Other studies have shown promising results in reducing mother-to-child transmission of hepatitis B with antiviral treatments, suggesting this approach may be effective.

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.

Where this trial is running

Guangzhou, Guangdong and 9 other locations

• 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)
• The Fifth Hospital of Shijiazhuang — Shijiazhuang, Hebei, China (NOT_YET_RECRUITING)
• Xiangya Hospital, Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (NOT_YET_RECRUITING)
• Beijing You 'an Hospital, Capital Medical University — Beijing, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Calvin.Q Pan

Conditions: Hepatitis B