Clinical trial NCT05440487: Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload
Official title: A Prospective Non-interventional Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Iron Overload
Keywords: chronic iron overload
Germany
NIS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female adult patients suffering from chronic iron overload receiving an iron chelation therapy

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

Detailed description: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Efficiency of iron overload therapy
timeFrame: Up to 24 months
Secondary outcomes:
measure: Number of patients treated with different iron chelators
timeFrame: Up to 24 months
measure: Number of patients with therapy switch
timeFrame: Up to 24 months
measure: Number of patients with dose adjustments
timeFrame: Up to 24 months
measure: Number of patients with myelodyplastic syndromes or myeloproliferative neoplasms experiencing a hematologic response during an iron chelation therapy
timeFrame: Up to 24 months
measure: Number of patients with AEs and SAE
timeFrame: Up to 24 months
measure: Number of patients with side effects
timeFrame: Up to 24 months
measure: Treatment Satisfaction Questionnaire to Medication (TSQM) 1.4
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Winnenden
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Heidenheim
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Bamberg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Munich
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Landshut
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Regensburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Garbsen
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Gelsenkirchen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Dortmund
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Aachen
country: Germany
facility: Novartis Investigative Site
state: North Rhine-Westphalia
city: Duisburg
country: Germany
facility: Novartis Investigative Site
state: North Rhine-Westphalia
city: Iserlohn
country: Germany
facility: Novartis Investigative Site
state: Northrhine Westfalia
city: Remscheid Innen
country: Germany
facility: Novartis Investigative Site
state: Northrhine Westfalia
city: Neuwied
country: Germany
facility: Novartis Investigative Site
state: Rhineland Palatinate
city: Dresden
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Pirna
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Zittau
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Luebeck
country: Germany
facility: Novartis Investigative Site
state: Schleswig-holstein
city: Erfurt
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Altenburg
country: Germany
facility: Novartis Investigative Site
city: Bad Liebenwerda
country: Germany
facility: Novartis Investigative Site
city: Bad Mergentheim
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Biberach
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bottrop
country: Germany
facility: Novartis Investigative Site
city: Bremerhaven
country: Germany
facility: Novartis Investigative Site
city: Celle
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Donauwoerth
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Goettingen
country: Germany
facility: Novartis Investigative Site
city: Goslar
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hameln
country: Germany
facility: Novartis Investigative Site
city: Hamm
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Heilbronn
country: Germany
facility: Novartis Investigative Site
city: Herrsching
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Hof
country: Germany
facility: Novartis Investigative Site
city: Kaiserslautern
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Koblenz
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Krefeld
country: Germany
facility: Novartis Investigative Site
city: Kronach
country: Germany
facility: Novartis Investigative Site
city: Lemgo
country: Germany
facility: Novartis Investigative Site
city: Luedenscheid
country: Germany
facility: Novartis Investigative Site
city: Lutherstadt Wittenberg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Moers
country: Germany
facility: Novartis Investigative Site
city: Muelheim
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Naunhof
country: Germany
facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Neustadt
country: Germany
facility: Novartis Investigative Site
city: Nordhorn
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Offenburg
country: Germany
facility: Novartis Investigative Site
city: Passau
country: Germany
facility: Novartis Investigative Site
city: Porta Westfalica
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Riesa
country: Germany
facility: Novartis Investigative Site
city: Roetha
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Saarbruecken
country: Germany
facility: Novartis Investigative Site
city: Saarbrücken
country: Germany
facility: Novartis Investigative Site
city: Schorndorf
country: Germany
facility: Novartis Investigative Site
city: Schwäbisch-Hall
country: Germany
facility: Novartis Investigative Site
city: Speyer
country: Germany
facility: Novartis Investigative Site
city: Stade
country: Germany
facility: Novartis Investigative Site
city: Stolberg
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Traunstein
country: Germany
facility: Novartis Investigative Site
city: Weiden
country: Germany
facility: Novartis Investigative Site
city: Wesel
country: Germany
facility: Novartis Investigative Site
city: Westerstede
country: Germany
facility: Novartis Investigative Site
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
city: Wuerselen
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: