Evaluation of referring HCPs’ and parents’/carers’ understanding of specific risks associated with Strimvelis™ treatment (STRIM-001)

Study identification

• EU PAS number:
  EUPAS19951
• Study ID:
  48878
• Official title and acronym:
  Evaluation of referring HCPs’ and parents’/carers’ understanding of specific risks associated with Strimvelis™ treatment (STRIM-001)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  To evaluate the effectiveness of routine and additional risk minimization measures by assessing the understanding of referring HCPs and parents/carers with regard to specific risks associated with Strimvelis. Surveys will be provided to referring HCPs and parents/carers of children approximately six months after treatment with Strimvelis.
• Study status:
  Finalised

Research institutions and networks

Institutions

Orchard Therapeutics

Study timelines

Date when funding contract was signed

Planned:31/03/2017

Actual:24/03/2017

Study start date

Planned:16/04/2018

Actual:12/04/2018

Data analysis start date

Planned:01/10/2020

Actual:30/08/2021

Date of final study report

Planned:30/09/2023

Actual:18/11/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Orchard Therapeutics

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)