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Phase 3, Randomized Clinical Trial to Assess the Efficacy and Safety of Tenofovir in Hepatitis B Virus Infected, s and e Antigen Positive, Pregnant Women to Prevent Perinatal Transmission Despite Infant Passive-active HBV Immunization

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Trial Profile

Phase 3, Randomized Clinical Trial to Assess the Efficacy and Safety of Tenofovir in Hepatitis B Virus Infected, s and e Antigen Positive, Pregnant Women to Prevent Perinatal Transmission Despite Infant Passive-active HBV Immunization

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Mar 2021

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At a glance

  • Drugs Tenofovir disoproxil fumarate (Primary)
  • Indications Hepatitis B
  • Focus Therapeutic Use
  • Acronyms iTAP

    • Most Recent Events

    • 22 Sep 2020 Results (n=196) from NCT00825929 and NCT01745822 retrospectively assessing the pregnancy effect and concomitant treatments on TFV exposure among women with HIV or HBV, published in the Journal of Clinical Pharmacology
    • 11 Mar 2020 Results (n=315) assessing immunization response in infants, presented at the 27th Conference on Retroviruses and Opportunistic Infections.
    • 07 Mar 2019 Results assessing changes in HBV DNA levels presented at the 26th Conference on Retroviruses and Opportunistic Infections

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