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
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
- 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.