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

Chronic Iron Overload Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215287
• Other study ID #: CICL670A2429
• Secondary ID: EUPAS104950
• Status: Not yet recruiting
• Start date: March 29, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Iron Overload
• Iron Overload

Intervention

Other:
• Physician survey
Survey to assess physicians' knowledge of Exjade posology and biological monitoring recommendations as described in the Educational Materials

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	Through study completion, an average of 6 months.