Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials

Completed

• Conditions: Chronic Iron Overload
• Interventions: Other: Physician survey

• Registration Number: NCT06215287
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The objective of this survey is to assess the knowledge of HCPs in relation to the recommended posology and biological monitoring for Exjade, based on the current locally valid Exjade educational materials (including the physician's reference checklist)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Study Start: 2024-01-12
• Study First Posted: 2024-01-22
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Physicians will be required to meet all of the following inclusion criteria:

• Must provide consent for participation
• Must spend ≥50% of time in direct patient care
• Have treated patients with transfusional iron overload or non-transfusion-dependent thalassemia with chelation therapy during the last 12 months.
• Have prescribed Exjade and/or generic deferasirox within the last 12 months.

Exclusion Criteria

Physicians meeting the following criterion will not be eligible to take the survey:

• Currently employed by a pharmaceutical company, health care company, market research company, advertising agency, or government agency involved in pharmaceutical research or marketing.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exjade Prescribers/HCP receiving Educational Materials	Physician survey	HCPs prescribing Exjade in the EU/EEA provided with Exjade Educational Materials

Primary Outcome Measures

Name	Time	Method
Mean percentage of correct responses related to knowledge of posology and biological monitoring recommendations as described in the Exjade EU Summary of Product Characteristics (SmPC)	Through study completion, an average of 6 months.	The primary endpoint is a composite endpoint based on the percentages of HCPs with correct responses to all questions included in the composite regarding the below information: * Administration and dosing of Exjade (deferasirox) FCT; * Biological monitoring

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Basel, Switzerland