A Two Part Seamless, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7034067 in Infants With Type 1 Spinal Muscular Atrophy

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Trial Profile

A Two Part Seamless, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7034067 in Infants With Type 1 Spinal Muscular Atrophy

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 12 Apr 2018

At a glance

  • Drugs RG 7916 (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms FIREFISH
  • Sponsors Chugai Pharmaceutical; Roche

    • Most Recent Events

    • 15 Mar 2018 According to a PTC Therapeutics media release, first patient has been dosed in the pivotal phase of this trial.
    • 27 Feb 2018 Planned End Date changed from 1 Jan 2021 to 2 Sep 2020.
    • 27 Feb 2018 Planned primary completion date changed from 30 Nov 2020 to 2 Sep 2020.
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