Trials / Approved For Marketing
Approved For MarketingNCT04877132
Compassionate Use Program for Olipudase Alfa Enzyme Replacement Therapy for Patients With Chronic Acid Sphingomyelinase Deficiency (ASMD)
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- —
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | olipudase alfa (GZ402665) | Patients will receive intravenous (IV) infusion of olipudase alfa |
Timeline
- First posted
- 2021-05-07
- Last updated
- 2022-09-19
Source: ClinicalTrials.gov record NCT04877132. Inclusion in this directory is not an endorsement.