Acid Sphingomyelinase Deficiency (ASMD): Data Analysis of Adult and Pediatric Patients on Early Access to Olipudase Alfa in France

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Objective: To describe the lung, spleen and liver outcomes of olipudase alfa Secondary

Objectives: * To describe the patient's characteristics * To describe conditions of olipudase alfa use * To describe safety data related to the use of olipudase alfa * To describe complementary effectiveness outcomes parameters

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• The patient, or the patient's parent(s)/guardian(s), has signed written informed consent.

• Patients with a confirmed diagnosis of ASMD under early access to olipudase alfa in France (ie, nominative compassionate use, pre marketing authorization early access, post marketing authorization early access).

• The patient has documented deficiency of acid sphingomyelinase in peripheral leukocytes, lymphocytes, or cultured fibroblasts.

• Male and female patients of all ages.

Locations
Other Locations
France
Investigational site in France
France
Time Frame
Start Date: 2022-06-10
Completion Date: 2024-12-31
Participants
Target number of participants: 40
Treatments
Cohort 1
Patients with a confirmed diagnosis of ASMD under early access to olipudase alfa in France
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov