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

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Jun 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

    • 23 Jun 2017 Status changed from recruiting to active, no longer recruiting.
    • 03 May 2017 This trial has been completed in Germany, according to European Clinical Trials Database.
    • 25 Jan 2017 Planned End Date changed from 1 May 2018 to 1 Jul 2018.
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