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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2018

At a glance

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

    • 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.
    • 07 Mar 2018 Result of substudy assessing the effect of Tenofovir disoproxil fumarate on maternal and infant bone mineral density one year after delivery or birth presented at the 25th Conference on Retroviruses and Opportunistic Infections
    • 07 Mar 2018 Results evaluating secondary end points through 12 months after delivery presented at the 25th Conference on Retroviruses and Opportunistic Infections
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