Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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20 November 2023 |
Main ID: |
NCT03232203 |
Date of registration:
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25/07/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Evaluating the Effectiveness of STRIMVELIS Risk Minimization Measures (RMMs)
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Scientific title:
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Evaluation of Referring HCPs' and Parents'/Carers' Understanding of Specific Risks Associated With Strimvelis™ Treatment |
Date of first enrolment:
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April 12, 2018 |
Target sample size:
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16 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03232203 |
Study type:
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Observational [Patient Registry] |
Study design:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Fondazione Telethon |
Address:
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Telephone:
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Email:
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Affiliation:
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Fondazione Telethon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- No exclusion criteria
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Severe Combined Immunodeficiency Due to ADA Deficiency
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Intervention(s)
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Drug: STRIMVELIS
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Primary Outcome(s)
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Proportion of Parents/Carers providing the correct response
[Time Frame: Up to 2 years]
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Proportion of HCPs providing the correct response
[Time Frame: Up to 2 years]
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Secondary ID(s)
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STRIM-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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