Chronic Iron OverloadNCT06215287
Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials
An observational study of Chronic Iron Overload, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Iron Overload
- What is being tested?
- Physician survey
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jan 2024to 15 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Exjade (deferasirox) prescribers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Chronic Iron Overload
- Being tested
- Physician survey
- Keywords
- Physician Survey,, PAS,, Deferasirox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician surveyOther
Survey to assess physicians' knowledge of Exjade posology and biological monitoring recommendations as described in the Educational Materials
| Study group | Role | What they receive |
|---|---|---|
| Exjade Prescribers/HCP receiving Educational Materials | HCPs prescribing Exjade in the EU/EEA provided with Exjade Educational Materials Receives: Other: Physician survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start12 Jan 2024
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Iron OverloadStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215287
- Sponsor's protocol ID
- CICL670A2429
- Other IDs
- EUPAS104950
- Status last verified
- May 2024
- First submitted
- 10 Jan 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials
- ClinicalTrials.gov ID
- NCT06215287
- Acronym / sponsor ID
- CICL670A2429
- Conditions
- Chronic Iron Overload
- Keywords
- Physician Survey,, PAS,, Deferasirox
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exjade Prescribers/HCP receiving Educational Materials | – | Other: Physician surveyHCPs prescribing Exjade in the EU/EEA provided with Exjade Educational Materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Exjade (deferasirox) prescribers
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Currently employed by a pharmaceutical company, health care company, market research company, advertising agency, or government agency involved in pharmaceutical research or marketing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician surveySurvey to assess physicians' knowledge of Exjade posology and biological monitoring recommendations as described in the Educational Materials | Other | Exjade Prescribers/HCP receiving Educational Materials |
Primary outcome
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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Iron Overload, run by Novartis Pharmaceuticals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.