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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05440487
Other study ID # CICL670ADE14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2015
Est. completion date October 29, 2021

Study information

Verified date October 2022
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 489
Est. completion date October 29, 2021
Est. primary completion date October 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Germany Novartis Investigative Site Aachen North Rhine-Westphalia
Germany Novartis Investigative Site Altenburg
Germany Novartis Investigative Site Aschaffenburg Bayern
Germany Novartis Investigative Site Bad Liebenwerda
Germany Novartis Investigative Site Bad Mergentheim
Germany Novartis Investigative Site Bamberg Bavaria
Germany Novartis Investigative Site Bayreuth Bayern
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Biberach
Germany Novartis Investigative Site Bochum
Germany Novartis Investigative Site Bonn Nordrhein Westfalen
Germany Novartis Investigative Site Bottrop
Germany Novartis Investigative Site Bremerhaven
Germany Novartis Investigative Site Celle
Germany Novartis Investigative Site Chemnitz
Germany Novartis Investigative Site Donauwoerth
Germany Novartis Investigative Site Dortmund Nordrhein-Westfalen
Germany Novartis Investigative Site Dresden Sachsen
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Duisburg North Rhine-Westphalia
Germany Novartis Investigative Site Erfurt Thueringen
Germany Novartis Investigative Site Erfurt
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Garbsen Lower Saxony
Germany Novartis Investigative Site Gelsenkirchen Nordrhein Westfalen
Germany Novartis Investigative Site Gera
Germany Novartis Investigative Site Goettingen
Germany Novartis Investigative Site Goslar
Germany Novartis Investigative Site Halle
Germany Novartis Investigative Site Hameln
Germany Novartis Investigative Site Hamm
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Heidenheim Baden-Wuerttemberg
Germany Novartis Investigative Site Heilbronn
Germany Novartis Investigative Site Herrsching
Germany Novartis Investigative Site Hildesheim
Germany Novartis Investigative Site Hildesheim
Germany Novartis Investigative Site Hof
Germany Novartis Investigative Site Iserlohn Northrhine Westfalia
Germany Novartis Investigative Site Kaiserslautern
Germany Novartis Investigative Site Kassel
Germany Novartis Investigative Site Kassel
Germany Novartis Investigative Site Koblenz
Germany Novartis Investigative Site Koeln
Germany Novartis Investigative Site Koeln Nordrhein-Westfalen
Germany Novartis Investigative Site Krefeld
Germany Novartis Investigative Site Kronach
Germany Novartis Investigative Site Landshut Bayern
Germany Novartis Investigative Site Lemgo
Germany Novartis Investigative Site Luebeck Schleswig-holstein
Germany Novartis Investigative Site Luedenscheid
Germany Novartis Investigative Site Lutherstadt Wittenberg
Germany Novartis Investigative Site Mannheim Baden-Wuerttemberg
Germany Novartis Investigative Site Marburg
Germany Novartis Investigative Site Minden
Germany Novartis Investigative Site Moers
Germany Novartis Investigative Site Muelheim
Germany Novartis Investigative Site Muenster
Germany Novartis Investigative Site Munchen
Germany Novartis Investigative Site München
Germany Novartis Investigative Site Munich Bavaria
Germany Novartis Investigative Site Naunhof
Germany Novartis Investigative Site Neuss
Germany Novartis Investigative Site Neustadt
Germany Novartis Investigative Site Neuwied Rhineland Palatinate
Germany Novartis Investigative Site Nordhorn
Germany Novartis Investigative Site Nuernberg
Germany Novartis Investigative Site Nuernberg
Germany Novartis Investigative Site Offenburg
Germany Novartis Investigative Site Passau
Germany Novartis Investigative Site Pirna Sachsen
Germany Novartis Investigative Site Porta Westfalica
Germany Novartis Investigative Site Potsdam
Germany Novartis Investigative Site Regensburg Bayern
Germany Novartis Investigative Site Remscheid Innen Northrhine Westfalia
Germany Novartis Investigative Site Riesa
Germany Novartis Investigative Site Roetha
Germany Novartis Investigative Site Rostock
Germany Novartis Investigative Site Saarbrücken
Germany Novartis Investigative Site Saarbruecken
Germany Novartis Investigative Site Schorndorf
Germany Novartis Investigative Site Schwäbisch-Hall
Germany Novartis Investigative Site Speyer
Germany Novartis Investigative Site Stade
Germany Novartis Investigative Site Stolberg
Germany Novartis Investigative Site Stuttgart
Germany Novartis Investigative Site Traunstein
Germany Novartis Investigative Site Weiden
Germany Novartis Investigative Site Wesel
Germany Novartis Investigative Site Westerstede
Germany Novartis Investigative Site Winnenden Baden Wuerttemberg
Germany Novartis Investigative Site Wolfsburg
Germany Novartis Investigative Site Wuerselen
Germany Novartis Investigative Site Wuerzburg
Germany Novartis Investigative Site Zittau Sachsen

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficiency of iron overload therapy Efficiency of iron chelation therapy is evaluated by the change of serum ferritin Up to 24 months
Secondary 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
Secondary 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
Secondary Number of patients with dose adjustments Number of patients with dose adjustments during the observational period are collected Up to 24 months
Secondary 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
Secondary Number of patients with AEs and SAE Number of patients with Adverse Events and Serious Adverse Events is collected Up to 24 months
Secondary 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
Secondary 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
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