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

Novartis Pharmaceuticals489 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

489

Conditions

Chronic Iron Overload

Interventions

Iron chelatorOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Locations (102)

Outcomes

Primary Outcomes

Efficiency of iron overload therapy

Efficiency of iron chelation therapy is evaluated by the change of serum ferritin

Time frame: Up to 24 months

Secondary Outcomes

Number of patients treated with different iron chelators

Number of patients treated with one of the three iron chelators approved in Germany.

Time frame: 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 From that date, the documentation of a change in therapy is no longer applicable.

Time frame: Up to 24 months

Number of patients with dose adjustments

Number of patients with dose adjustments during the observational period are collected

Time frame: 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

Time frame: Up to 24 months

Number of patients with AEs and SAE

Number of patients with Adverse Events and Serious Adverse Events is collected

Time frame: 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.

Data from ClinicalTrials.gov

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Novartis Investigative Site

Heidenheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Winnenden, Baden-Wurttemberg, Germany

Novartis Investigative Site

Aschaffenburg, Bavaria, Germany

Novartis Investigative Site

Bamberg, Bavaria, Germany

Novartis Investigative Site

Bayreuth, Bavaria, Germany

Novartis Investigative Site

Landshut, Bavaria, Germany

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Regensburg, Bavaria, Germany

Novartis Investigative Site

Garbsen, Lower Saxony, Germany

...and 92 more locations