Ignite Creation Date:
2024-05-06 @ 10:21 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03232203
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2017-07-25
Brief Title:
Evaluating the Effectiveness of STRIMVELIS Risk Minimization Measures RMMs
Sponsor:
Fondazione Telethon
Organization:
Fondazione Telethon
Study Overview
Official Title:
Evaluation of Referring HCPs and ParentsCarers Understanding of Specific Risks Associated With Strimvelis Treatment
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 treatment of patients with ADA- severe combined immunodeficiency SCID for whom suitable human leukocyte antigen HLA-matched related stem cell donor is not available The objective of this study is to evaluate the effectiveness of routine and additional risk minimization measures by assessing the understanding of referring health care providers HCPs and parentscarers hereby referred as participants with regard to the specific risks associated with STRIMVELIS In this cross-sectional study surveys will be provided to referring HCPs and parentscarers of children approximately six months after treatment with STRIMVELIS The study will recruit for approximately two years or until a maximum of 10 referring HCPs and 10 parentscarers have completed their respective surveys whichever occurs first
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None