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A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Studyto Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illnessin the Elderly

Trial Profile

A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Studyto Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illnessin the Elderly

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2019

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At a glance

  • Drugs Dactolisib (Primary)
  • Indications Respiratory tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PROTECTOR; PROTECTOR-1
  • Sponsors resTORbio
  • Most Recent Events

    • 15 Nov 2019 According to a resTORbio media release, the company will host a conference call at 8:00 a.m. EST today to review these pivotal results and provide an update on additional clinical development plans for RTB101.
    • 15 Nov 2019 According to a resTORbio media release, the company plans to conduct detailed analyses of this trial, including additional data on safety and secondary and exploratory endpoints, which are not available at this time, with the goal of gaining insights that may explain the difference in RTB101 activity observed in PROTECTOR 1 as compared to prior Phase 2 studies.
    • 15 Nov 2019 Primary endpoint (Reduction in the percentage of subjects with clinically symptomatic respiratory illness, defined as illness associated with a respiratory tract infection, or RTI, based on prespecified diagnostic criteria, with or without laboratory confirmation of a pathogen: RTB101 versus Placebo) has not been met, according to a resTORbio media release.
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