An Open-label Ascending Dose Cohort Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of neoGAA (GZ402666) in Patients With Infantile-onset Pompe Disease Treated With Alglucosidase Alfa Who Demonstrate Clinical Decline or Sub-optimal Clinical Response

Trial Profile

An Open-label Ascending Dose Cohort Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of neoGAA (GZ402666) in Patients With Infantile-onset Pompe Disease Treated With Alglucosidase Alfa Who Demonstrate Clinical Decline or Sub-optimal Clinical Response

Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Jul 2017

At a glance

  • Drugs GZ 402666 (Primary) ; Alglucosidase alfa
  • Indications Glycogen storage disease type II
  • Focus Adverse reactions
  • Acronyms Mini-COMET
  • Sponsors Sanofi Genzyme
  • Most Recent Events

    • 04 Jul 2017 Planned End Date changed from 1 Jan 2022 to 1 Feb 2022.
    • 04 Jul 2017 Planned primary completion date changed from 1 Jan 2022 to 1 Feb 2022.
    • 04 Jul 2017 Planned initiation date changed from 1 Jul 2017 to 2 Aug 2017.
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