Evaluating the Effectiveness of STRIMVELIS Risk Minimization Measures (RMMs)

Plain-language summary

This study evaluated how effective the risk minimization measures (educational materials) for STRIMVELIS, a gene therapy, have been. It involved healthcare professionals who had referred patients for STRIMVELIS treatment and the parents or carers of children who had received it. The study was conducted as a trial without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Fondazione Telethon

Intervention

STRIMVELIS

Start date

4/12/2018

Estimated completion

6/25/2021

Countries

Italy

Related genes

Locations

• Milan, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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