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Safety and Efficacy of TAF to Prevent MTCT of HBV in Middle/Late Pregnancies With High HBV DNA Load

Recruitingn/aAges 20 Years - 40 YearsFemaleXingfei Pan
NCT05466071 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Mother-to-child transmission (MTCT) is still the main transmission route of HBV in high-endemic areas, such as China, sub-Saharan Africa, etc. Some infants born of mothers with high HBV DNA load (≥2×10\^5 IU/ml) are still infected with HBV even if these infants receive the combined immunization on time. Therefore, guidelines including AASLD and EASL recommend that pregnant women with high HBV DNA load should take antiviral drugs (tenofovir disoproxil fumarate or telbivudine) to reduce MTCT of HBV from gestation 24-28 weeks. However, side effects of TDF on infants are reported. For example, neutropenia and the decrease of bone mineral density are found in early age infants who are ever exposed to TDF during their fetal life. Tenofovir alafenamide (TAF), a new prodrug of tenofovir (TFV), has a higher antiviral potency, a higher peripheral blood mononuclear cell (PBMC) intracellular tenof

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age of 20-40 years. * Positive for HBsAg ≥6 months. * HBV DNA load of ≥ 2×10\^5 IU/ml. * Gestation 24-28 weeks . * Pregnancies are orally administrated with TAF (25mg/day) or TDF (300mg/day) from 24-28 weeks of gestation. * The good compliance of patients. Exclusion Criteria: * Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease. * Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity. * Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators. * Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality. * Clinical signs of threatened miscarriage. * History of complication of pregnancy. * History of nucleoside analogues (NA) treatment.
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What it tests

  • Not listed
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Where

1 site
The Third Affiliated Hospital, Guangzhou Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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