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COMPLETED
NCT06949358
PHASE2

A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in France

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This was an open-label study to evaluate safety and tolerability and provide enzyme replacement therapy (ERT) with olipudase alfa to patients with acid sphingomyelinase deficiency (ASMD) who completed the DFI12712 or the LTS13632 Study in France until olipudase alfa reimbursement was granted in France. Study and treatment duration: The period between the participant's completion of Study DFI12712 or LTS13632 and olipudase alfa reimbursement was available in France. In case reimbursement was not obtained, this study ended 5 years after starting. Visit frequency: every 2 weeks.

Official title: A Long-Term Follow-up Study to Evaluate Safety and Tolerability of Olipudase Alfa in Patients Who Completed the DFI12712 or the LTS13632 Study in France

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2021-11-18

Completion Date

2025-04-08

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

Olipudase alfa

Pharmaceutical form:Powder for concentrate for solution for infusion-Route of administration:intravenous infusion

Locations (2)

Investigational Site Number : 2500002

Bron, France

Investigational Site Number : 2500001

Paris, France