NCT02292654View on ClinicalTrials.gov

Safety, Tolerability, PK, and Efficacy Evaluation of Repeat Ascending Doses of Olipudase Alfa in Pediatric Patients <18 Years of Age With Acid Sphingomyelinase Deficiency

PHASE1/PHASE2CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

May 1, 2015

Primary Completion Date

December 9, 2019

Study Completion Date

December 9, 2019

Conditions

Sphingomyelin Lipidosis

Interventions

DRUG

Olipudase alfa

Pharmaceutical form: powder for concentrate for solution for infusion Route of administration: intravenous infusion

Trial Locations (6)

10029

Investigational Site Number 840001, New York

33100

Investigational Site Number 380001, Udine

55131

Investigational Site Number 276001, Mainz

69677

Investigational Site Number 250002, Bron

90035 003

Investigational Site Number 076001, Porto Alegre

M13 9WL

Investigational Site Number 826001, Manchester

All Listed Sponsors

lead

Genzyme, a Sanofi Company

INDUSTRY

NCT02292654 - Safety, Tolerability, PK, and Efficacy Evaluation of Repeat Ascending Doses of Olipudase Alfa in Pediatric Patients <18 Years of Age With Acid Sphingomyelinase Deficiency | Biotech Hunter | Biotech Hunter