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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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2019

At a glance

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

    • 07 Mar 2019 Results assessing changes in HBV DNA levels presented at the 26th Conference on Retroviruses and Opportunistic Infections
    • 22 Feb 2019 Status changed from active, no longer recruiting to completed.
    • 08 Mar 2018 Results (n=331) assessing efficacy and tolerability of tenofovir disoproxil fumarate administered for the prevention of vertical transmission of hepatitis B in pregnant females, were published in the New England Journal of Medicine.
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