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: 23 Aug 2017

At a glance

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

    • 16 Feb 2017 Primary endpoint (Infants Hepatitis B infection status at 6 months of age) has not been met,according to the results published at the 24th Conference on Retroviruses and Opportunistic Infections
    • 16 Feb 2017 Results presented at the 24th Conference on Retroviruses and Opportunistic Infections
    • 29 Aug 2016 Planned End Date changed from 1 Oct 2017 to 1 Oct 2018.
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