Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT06949358
Brief Summary:
This is 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 is granted in France.
Study and treatment duration:
The period between the patient's completion of Study DFI12712 or LTS13632 and olipudase alfa reimbursement is available in France.
In case reimbursement will not be obtained, this study will end 5 years after starting.
Visit frequency: every 2 weeks.
Study:
NCT06949358
Study Brief:
Protocol Section:
NCT06949358