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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05440487
Collaborator
(none)
489
Enrollment
103
Locations
73.5
Actual Duration (Months)
4.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Iron chelator

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.

Study Design

Study Type:
Observational
Actual Enrollment :
489 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Non-interventional Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload
Actual Study Start Date :
Sep 15, 2015
Actual Primary Completion Date :
Oct 29, 2021
Actual Study Completion Date :
Oct 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Iron chelator

Patients prescribed with Iron Chelators

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.

Outcome Measures

Primary Outcome Measures

  1. Efficiency of iron overload therapy [Up to 24 months]

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

Secondary Outcome Measures

  1. Number of patients treated with different iron chelators [Up to 24 months]

    Number of patients treated with one of the three iron chelators approved in Germany.

  2. Number of patients with therapy switch [Up to 24 months]

    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.

  3. Number of patients with dose adjustments [Up to 24 months]

    Number of patients with dose adjustments during the observational period are collected

  4. Number of patients with myelodyplastic syndromes or myeloproliferative neoplasms experiencing a hematologic response during an iron chelation therapy [Up to 24 months]

    The analysis of a hematological response to iron chelation therapy should follow the effective criteria of the international working group

  5. Number of patients with AEs and SAE [Up to 24 months]

    Number of patients with Adverse Events and Serious Adverse Events is collected

  6. Number of patients with side effects [Up to 24 months]

    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.

  7. Treatment Satisfaction Questionnaire to Medication (TSQM) 1.4 [Up to 24 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Winnenden Baden Wuerttemberg Germany 71364
2 Novartis Investigative Site Heidenheim Baden-Wuerttemberg Germany 89518
3 Novartis Investigative Site Mannheim Baden-Wuerttemberg Germany 68305
4 Novartis Investigative Site Bamberg Bavaria Germany 96052
5 Novartis Investigative Site Munich Bavaria Germany 80797
6 Novartis Investigative Site Aschaffenburg Bayern Germany 63739
7 Novartis Investigative Site Bayreuth Bayern Germany 95445
8 Novartis Investigative Site Landshut Bayern Germany 84028
9 Novartis Investigative Site Regensburg Bayern Germany 93053
10 Novartis Investigative Site Garbsen Lower Saxony Germany 30827
11 Novartis Investigative Site Bonn Nordrhein Westfalen Germany 53177
12 Novartis Investigative Site Gelsenkirchen Nordrhein Westfalen Germany 45879
13 Novartis Investigative Site Dortmund Nordrhein-Westfalen Germany 44309
14 Novartis Investigative Site Koeln Nordrhein-Westfalen Germany 50677
15 Novartis Investigative Site Aachen North Rhine-Westphalia Germany 52064
16 Novartis Investigative Site Duisburg North Rhine-Westphalia Germany 47166
17 Novartis Investigative Site Iserlohn Northrhine Westfalia Germany 58644
18 Novartis Investigative Site Remscheid Innen Northrhine Westfalia Germany 42859
19 Novartis Investigative Site Neuwied Rhineland Palatinate Germany 56564
20 Novartis Investigative Site Dresden Sachsen Germany 01307
21 Novartis Investigative Site Pirna Sachsen Germany 01796
22 Novartis Investigative Site Zittau Sachsen Germany 02763
23 Novartis Investigative Site Luebeck Schleswig-holstein Germany 23563
24 Novartis Investigative Site Erfurt Thueringen Germany 99084
25 Novartis Investigative Site Altenburg Germany 04600
26 Novartis Investigative Site Bad Liebenwerda Germany 04924
27 Novartis Investigative Site Bad Mergentheim Germany 97980
28 Novartis Investigative Site Berlin Germany 10407
29 Novartis Investigative Site Berlin Germany 10709
30 Novartis Investigative Site Berlin Germany 12487
31 Novartis Investigative Site Berlin Germany 12627
32 Novartis Investigative Site Berlin Germany 13357
33 Novartis Investigative Site Berlin Germany 14089
34 Novartis Investigative Site Biberach Germany 88400
35 Novartis Investigative Site Bochum Germany 44787
36 Novartis Investigative Site Bottrop Germany 46236
37 Novartis Investigative Site Bremerhaven Germany 27568
38 Novartis Investigative Site Celle Germany 29221
39 Novartis Investigative Site Chemnitz Germany 09113
40 Novartis Investigative Site Donauwoerth Germany 86609
41 Novartis Investigative Site Dresden Germany 01127
42 Novartis Investigative Site Dresden Germany 01307
43 Novartis Investigative Site Erfurt Germany 99085
44 Novartis Investigative Site Essen Germany 45136
45 Novartis Investigative Site Gera Germany 07548
46 Novartis Investigative Site Goettingen Germany 37073
47 Novartis Investigative Site Goslar Germany 38642
48 Novartis Investigative Site Halle Germany 06110
49 Novartis Investigative Site Hameln Germany 31785
50 Novartis Investigative Site Hamm Germany 59063
51 Novartis Investigative Site Hannover Germany 30161
52 Novartis Investigative Site Hannover Germany 30170
53 Novartis Investigative Site Heidelberg Germany 69115
54 Novartis Investigative Site Heilbronn Germany 74072
55 Novartis Investigative Site Herrsching Germany 82211
56 Novartis Investigative Site Hildesheim Germany 31134
57 Novartis Investigative Site Hildesheim Germany 31135
58 Novartis Investigative Site Hof Germany 95028
59 Novartis Investigative Site Kaiserslautern Germany 67655
60 Novartis Investigative Site Kassel Germany 34119
61 Novartis Investigative Site Kassel Germany 34125
62 Novartis Investigative Site Koblenz Germany 56068
63 Novartis Investigative Site Koeln Germany 50937
64 Novartis Investigative Site Krefeld Germany 47805
65 Novartis Investigative Site Kronach Germany 96317
66 Novartis Investigative Site Lemgo Germany 32657
67 Novartis Investigative Site Luedenscheid Germany 58507
68 Novartis Investigative Site Lutherstadt Wittenberg Germany 06886
69 Novartis Investigative Site Marburg Germany 35037
70 Novartis Investigative Site Minden Germany 32429
71 Novartis Investigative Site Moers Germany 47441
72 Novartis Investigative Site Muelheim Germany 45468
73 Novartis Investigative Site Muenster Germany 48149
74 Novartis Investigative Site Munchen Germany 81479
75 Novartis Investigative Site München Germany 81377
76 Novartis Investigative Site Naunhof Germany 04683
77 Novartis Investigative Site Neuss Germany 41462
78 Novartis Investigative Site Neustadt Germany 31535
79 Novartis Investigative Site Nordhorn Germany 48527
80 Novartis Investigative Site Nuernberg Germany 90403
81 Novartis Investigative Site Nuernberg Germany 90419
82 Novartis Investigative Site Offenburg Germany 77654
83 Novartis Investigative Site Passau Germany 94036
84 Novartis Investigative Site Porta Westfalica Germany 32457
85 Novartis Investigative Site Potsdam Germany 14467
86 Novartis Investigative Site Riesa Germany 01587
87 Novartis Investigative Site Roetha Germany 04571
88 Novartis Investigative Site Rostock Germany 18057
89 Novartis Investigative Site Saarbruecken Germany 66113
90 Novartis Investigative Site Saarbrücken Germany 66113
91 Novartis Investigative Site Schorndorf Germany 73614
92 Novartis Investigative Site Schwäbisch-Hall Germany 74523
93 Novartis Investigative Site Speyer Germany 67346
94 Novartis Investigative Site Stade Germany
95 Novartis Investigative Site Stolberg Germany 52222
96 Novartis Investigative Site Stuttgart Germany 70178
97 Novartis Investigative Site Traunstein Germany 83278
98 Novartis Investigative Site Weiden Germany 92637
99 Novartis Investigative Site Wesel Germany 46485
100 Novartis Investigative Site Westerstede Germany 26655
101 Novartis Investigative Site Wolfsburg Germany 38440
102 Novartis Investigative Site Wuerselen Germany 52146
103 Novartis Investigative Site Wuerzburg Germany 97080

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05440487
Other Study ID Numbers:
  • CICL670ADE14
First Posted:
Jun 30, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Novartis Pharmaceuticals
chronic iron overload
Germany
NIS
Additional relevant MeSH terms:
Iron Overload
Chelating Agents

Study Results

No Results Posted as of Jun 30, 2022