Last updated: 01/10/2019 20:00:37
This product has been transferred to Orchard Therapeutics Limited. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov
Evaluating the Effectiveness of STRIMVELIS Risk Minimization Measures (RMMs)
GSK study ID
205881
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Evaluation of referring HCPs’ and parents’/carers’ understanding of specific risks associated with Strimvelis™ treatment
Trial description: STRIMVELIS is a medicinal product developed by GSK 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 parents/carers (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 parents/carers of children approximately six months after treatment with STRIMVELIS. The study will recruit for approximately two years until 10 referring HCPs and 10 parents/carers have completed their respective surveys. STRIMVELIS is a trade mark of the GSK group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of HCPs providing the correct response
Timeframe: Up to 2 years
Proportion of Parents/Carers providing the correct response
Timeframe: Up to 2 years
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
2020-30-09
Observational study model:
Cohort
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Severe combined immunodeficiency due to adenosine deaminase deficiency
Product
GSK2696273
Collaborators
Not applicable
Study date(s)
April 2018 to September 2020
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- HCPs or HCPs’ close family members may not have been employees of GSK, Pharmaceutical Product Development, LLC (PPD), the Food and Drug Administration (FDA), or the European Medicines Agency (EMA).
- HCPs must be licensed
- No exclusion criteria
Inclusion and exclusion criteria
Inclusion criteria:
- HCPs or HCPs’ close family members may not have been employees of GSK, 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 GSK, 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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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