A Phase 1/2, Multi-Center, Open-Label, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Olipudase Alfa in Pediatric Patients Aged <18 Years With Acid Sphingomyelinase Deficiency

Trial Profile

A Phase 1/2, Multi-Center, Open-Label, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Olipudase Alfa in Pediatric Patients Aged <18 Years With Acid Sphingomyelinase Deficiency

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Dec 2017

At a glance

  • Drugs Olipudase alfa (Primary)
  • Indications Niemann-Pick diseases
  • Focus Adverse reactions
  • Acronyms ASCEND-Peds
  • Sponsors Sanofi; Sanofi Genzyme
  • Most Recent Events

    • 10 Oct 2017 Planned primary completion date changed from 24 Sep 2019 to 4 Jun 2019.
    • 09 Oct 2017 Planned End Date changed from 1 Sep 2019 to 24 Sep 2019.
    • 09 Oct 2017 Planned primary completion date changed from 1 Sep 2019 to 24 Sep 2019.
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