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Compassionate Use Program for Olipudase Alfa Enzyme Replacement Therapy for Patients With Chronic Acid Sphingomyelinase Deficiency (ASMD)

NCT04877132 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2022-09-19

No results posted yet for this study

Summary

The objective of this program is to provide access to enzyme replacement therapy (ERT) with olipudase alfa for certain patients with ASMD, a severe, life threatening disease, that could not participate in the olipudase clinical trials. The program will provide access to olipudase alfa prior to registration and the availability of commercial product (including reimbursement where applicable) in the country of the patient.

Conditions

  • Sphingomyelin Lipidosis

Interventions

DRUG

olipudase alfa (GZ402665)

Patients will receive intravenous (IV) infusion of olipudase alfa

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877132 on ClinicalTrials.gov