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

NCT05440487 | Completed

• 1 other identifier: CICL670ADE14
• Study Type: observational
• Target: 489
• Locations: 1 country
• Sites: 102

Brief Summary

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

Conditions

Chronic Iron Overload

Keywords

chronic iron overload; Germany; NIS

Outcome Measures

Primary Outcomes (1)

• Efficiency of iron overload therapy

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

  Up to 24 months

Secondary Outcomes (7)

• Number of patients treated with different iron chelators

  Up to 24 months

• Number of patients with therapy switch

  Up to 24 months

• Number of patients with dose adjustments

  Up to 24 months

• Number of patients with myelodyplastic syndromes or myeloproliferative neoplasms experiencing a hematologic response during an iron chelation therapy

  Up to 24 months

• Number of patients with AEs and SAE

  Up to 24 months

Study Arms (1)

Iron chelator

Patients prescribed with Iron Chelators

Other: Iron chelator

Interventions

Iron chelator 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.

Iron chelator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female adult patients suffering from chronic iron overload receiving an iron chelation therapy

You may qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (102)

Novartis Investigative Site

Heidenheim, Baden-Wurttemberg, 89518, Germany

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Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 68305, Germany

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Novartis Investigative Site

Winnenden, Baden-Wurttemberg, 71364, Germany

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Novartis Investigative Site

Aschaffenburg, Bavaria, 63739, Germany

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Novartis Investigative Site

Bamberg, Bavaria, 96052, Germany

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Bayreuth, Bavaria, 95445, Germany

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Landshut, Bavaria, 84028, Germany

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Munich, Bavaria, 80797, Germany

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Regensburg, Bavaria, 93053, Germany

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Garbsen, Lower Saxony, 30827, Germany

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Aachen, North Rhine-Westphalia, 52064, Germany

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Bonn, North Rhine-Westphalia, 53177, Germany

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Cologne, North Rhine-Westphalia, 50677, Germany

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Dortmund, North Rhine-Westphalia, 44309, Germany

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Duisburg, North Rhine-Westphalia, 47166, Germany

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Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

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Iserlohn, Northrhine Westfalia, 58644, Germany

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Remscheid Innen, Northrhine Westfalia, 42859, Germany

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Neuwied, Rhineland-Palatinate, 56564, Germany

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Dresden, Saxony, 01307, Germany

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Pirna, Saxony, 01796, Germany

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Zittau, Saxony, 02763, Germany

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Lübeck, Schleswig-Holstein, 23563, Germany

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Erfurt, Thuringia, 99084, Germany

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Altenburg, 04600, Germany

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Bad Liebenwerda, 04924, Germany

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Bad Mergentheim, 97980, Germany

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Berlin, 10407, Germany

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Berlin, 10709, Germany

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Berlin, 12487, Germany

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Berlin, 12627, Germany

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Berlin, 13357, Germany

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Berlin, 14089, Germany

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Biberach, 88400, Germany

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Bochum, 44787, Germany

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Bottrop, 46236, Germany

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Bremerhaven, 27568, Germany

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Celle, 29221, Germany

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Chemnitz, 09113, Germany

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Cologne, 50937, Germany

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Donauwörth, 86609, Germany

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Dresden, 01127, Germany

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Dresden, 01307, Germany

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Erfurt, 99085, Germany

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Essen, 45136, Germany

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Gera, 07548, Germany

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Goslar, 38642, Germany

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Göttingen, 37073, Germany

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Halle, 06110, Germany

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Hamelin, 31785, Germany

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Hamm, 59063, Germany

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Hanover, 30161, Germany

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Hanover, 30170, Germany

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Heidelberg, 69115, Germany

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Heilbronn, 74072, Germany

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Herrsching am Ammersee, 82211, Germany

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Hildesheim, 31134, Germany

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Hildesheim, 31135, Germany

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Hof, 95028, Germany

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Kaiserslautern, 67655, Germany

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Kassel, 34119, Germany

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Kassel, 34125, Germany

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Koblenz, 56068, Germany

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Krefeld, 47805, Germany

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Kronach, 96317, Germany

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Lemgo, 32657, Germany

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Lüdenscheid, 58507, Germany

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Marburg, 35037, Germany

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Minden, 32429, Germany

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Moers, 47441, Germany

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Mülheim, 45468, Germany

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Novartis Investigative Site

München, 81377, Germany

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Novartis Investigative Site

München, 81479, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Naunhof, 04683, Germany

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Neuss, 41462, Germany

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Neustadt, 31535, Germany

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Nordhorn, 48527, Germany

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Nuremberg, 90403, Germany

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Nuremberg, 90419, Germany

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Offenburg, 77654, Germany

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Passau, 94036, Germany

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Porta Westfalica, 32457, Germany

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Potsdam, 14467, Germany

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Novartis Investigative Site

Riesa, 01587, Germany

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Rostock, 18057, Germany

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Rötha, 04571, Germany

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Novartis Investigative Site

Saarbrücken, 66113, Germany

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Novartis Investigative Site

Schorndorf, 73614, Germany

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Novartis Investigative Site

Schwäbisch Hall, 74523, Germany

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Novartis Investigative Site

Speyer, 67346, Germany

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Novartis Investigative Site

Stade, Germany

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Novartis Investigative Site

Stolberg, 52222, Germany

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Novartis Investigative Site

Stuttgart, 70178, Germany

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Traunstein, 83278, Germany

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Weiden, 92637, Germany

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Wesel, 46485, Germany

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Novartis Investigative Site

Westerstede, 26655, Germany

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Novartis Investigative Site

Wittenberg, 06886, Germany

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Novartis Investigative Site

Wolfsburg, 38440, Germany

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Novartis Investigative Site

Würselen, 52146, Germany

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Novartis Investigative Site

Würzburg, 97080, Germany

Location

Related Links

• Results for CICL670ADE14 from the Novartis Clinical Trials Website

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 30, 2022
• Study Start: September 15, 2015
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (102)