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

NCT ID: NCT05440487

Last Updated: 2022-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

489 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-15

Study Completion Date

2021-10-29

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.

Conditions

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Chronic Iron Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Iron chelator

Patients prescribed with Iron Chelators

Iron chelator

Intervention Type OTHER

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.

Interventions

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Iron chelator

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.

Intervention Type OTHER

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Heidenheim, Baden-Wurttemberg, Germany

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Mannheim, Baden-Wurttemberg, Germany

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Winnenden, Baden-Wurttemberg, Germany

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Aschaffenburg, Bavaria, Germany

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Bamberg, Bavaria, Germany

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Bayreuth, Bavaria, Germany

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Landshut, Bavaria, Germany

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Munich, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Garbsen, Lower Saxony, Germany

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Aachen, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Duisburg, North Rhine-Westphalia, Germany

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Gelsenkirchen, North Rhine-Westphalia, Germany

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Iserlohn, Northrhine Westfalia, Germany

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Remscheid Innen, Northrhine Westfalia, Germany

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Neuwied, Rhineland-Palatinate, Germany

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Dresden, Saxony, Germany

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Pirna, Saxony, Germany

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Zittau, Saxony, Germany

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Lübeck, Schleswig-Holstein, Germany

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Erfurt, Thuringia, Germany

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Altenburg, , Germany

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Bad Liebenwerda, , Germany

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Bad Mergentheim, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Biberach, , Germany

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Bochum, , Germany

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Bottrop, , Germany

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Bremerhaven, , Germany

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Celle, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Donauwörth, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Erfurt, , Germany

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Essen, , Germany

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Gera, , Germany

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Goslar, , Germany

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Göttingen, , Germany

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Halle, , Germany

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Hamelin, , Germany

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Hamm, , Germany

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Hanover, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Heilbronn, , Germany

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Herrsching am Ammersee, , Germany

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Hildesheim, , Germany

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Hildesheim, , Germany

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Hof, , Germany

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Kaiserslautern, , Germany

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Kassel, , Germany

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Kassel, , Germany

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Koblenz, , Germany

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Krefeld, , Germany

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Kronach, , Germany

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Lemgo, , Germany

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Lüdenscheid, , Germany

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Marburg, , Germany

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Minden, , Germany

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Moers, , Germany

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Mülheim, , Germany

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München, , Germany

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München, , Germany

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Münster, , Germany

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Naunhof, , Germany

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Neuss, , Germany

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Neustadt, , Germany

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Nordhorn, , Germany

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Nuremberg, , Germany

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Nuremberg, , Germany

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Offenburg, , Germany

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Passau, , Germany

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Porta Westfalica, , Germany

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Potsdam, , Germany

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Riesa, , Germany

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Rostock, , Germany

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Rötha, , Germany

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Saarbrücken, , Germany

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Schorndorf, , Germany

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Schwäbisch Hall, , Germany

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Speyer, , Germany

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Stade, , Germany

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Stolberg, , Germany

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Stuttgart, , Germany

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Traunstein, , Germany

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Weiden, , Germany

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Wesel, , Germany

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Westerstede, , Germany

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Wittenberg, , Germany

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Wolfsburg, , Germany

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Würselen, , Germany

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Würzburg, , Germany

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Countries

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Germany

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17984

Results for CICL670ADE14 from the Novartis Clinical Trials Website

Other Identifiers

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CICL670ADE14

Identifier Type: -

Identifier Source: org_study_id

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