Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload

Study Overview
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Brief Summary
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This is a prospective, multicenter, non-interventional study. Findings are analyzed using epidemiological methods.

Detailed Description
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This NIS shall document the therapy of chronic iron overload in a broad patient population with either of the approved iron chelators in Germany. The choice of patients and the therapy according to the SmPC follows the clinical routine exclusively. The regular observation time per patient is 24 months. Corresponding to the clinical routine, follow up visits can be documented after approximately 1, 3, 6, 9, 12 and 18 month with a close out visit after 24 month. In case the iron chelator is switched, the visit scheme should be passed through once again.

Official Title
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A Prospective Non-interventional Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload

Conditions
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Chronic Iron Overload

Intervention / Treatment
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* Other: Iron chelator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adult patients suffering from chronic iron overload who never received an iron chelator directly before starting an iron chelation therapy who received an iron chelation therapy for less than 6 month who interrupted an iron chelation therapy for longer than 6 months and will receive an iron chelation therapy again who signed the informed consent Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Iron chelator<br>Patients prescribed with Iron Chelators | Other: Iron chelator<br>* There is no treatment allocation. Patients administered approved Iron chelators by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency of iron overload therapy | Efficiency of iron chelation therapy is evaluated by the change of serum ferritin | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients treated with different iron chelators | Number of patients treated with one of the three iron chelators approved in Germany. | Up to 24 months | 
| Number of patients with therapy switch | Number of patients with therapy switch in the standard clinical routine and the reason for the switch. The documentation of a therapy change is limited to the end of recruitment time (10/31/2019). From that date, the documentation of a change in therapy is no longer applicable. | Up to 24 months | 
| Number of patients with dose adjustments | Number of patients with dose adjustments during the observational period are collected | Up to 24 months | 
| Number of patients with myelodyplastic syndromes or myeloproliferative neoplasms experiencing a hematologic response during an iron chelation therapy | The analysis of a hematological response to iron chelation therapy should follow the effective criteria of the international working group | Up to 24 months | 
| Number of patients with AEs and SAE | Number of patients with Adverse Events and Serious Adverse Events is collected | Up to 24 months | 
| Number of patients with side effects | Side effects are defined as all adverse events, which are suspected to have a causality with the respective iron chelator. All events are reported in the eCRF and causality with iron chelator treatment is requested. | Up to 24 months | 
| Treatment Satisfaction Questionnaire to Medication (TSQM) 1.4 | TSQM is used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain. | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic iron overload, Germany, NIS