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

Chronic Iron Overload Clinical Trial

— EXCALIBUR  

Official title:

A Prospective Non-interventional Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440487
• Other study ID #: CICL670ADE14
• Status: Completed
• 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
• 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: -

Related Conditions & MeSH terms

• Chronic Iron Overload
• Iron Overload

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

External Links

•   Results for CICL670ADE14 from the Novartis Clinical Trials Website