Status:
COMPLETED
Evaluating the Effectiveness of STRIMVELIS Risk Minimization Measures (RMMs)
Lead Sponsor:
Fondazione Telethon
Conditions:
Severe Combined Immunodeficiency Due to ADA Deficiency
Eligibility:
All Genders
18+ years
Brief Summary
STRIMVELIS is a medicinal product that restores adenosine deaminase (ADA) function in hematopoietic cell lineages, thereby preventing impaired immune function. STRIMVELIS is indicated for the treatmen...
Eligibility Criteria
Inclusion
- HCPs or HCPs' close family members may not have been employees of Orchard, Pharmaceutical Product Development, LLC (PPD), the Food and Drug Administration (FDA), or the European Medicines Agency (EMA).
- HCPs must be licensed
- An HCP must not have previously completed a survey regarding STRIMVELIS educational materials.
- An HCP must have previously referred a patient for STRIMVELIS treatment.
- Parents/carers or parents'/carers' close family members may not have been employees of Orchard, PPD, FDA, or EMA.
- A parent/carer must not have previously completed a survey regarding STRIMVELIS educational materials.
- A parent's or carer's child must have previously received treatment with STRIMVELIS
Exclusion
- No exclusion criteria
Key Trial Info
Start Date :
April 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03232203
Start Date
April 12 2018
End Date
June 25 2021
Last Update
November 14 2023
Active Locations (1)
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1
Ospedale San Raffaele - Telethon Institute for Gene Therapy (OSR-TIGET)
Milan, Italy, 20132