Chronic Iron OverloadEXCALIBURNCT05440487
Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload
An observational study of Chronic Iron Overload, run by Novartis Pharmaceuticals at 102 sites in Germany.
Trial summary
This is a prospective, multicenter, non-interventional study. Findings are analyzed using epidemiological methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Iron Overload
- What is being tested?
- Iron chelator
- How many people
- 489 participants
- Where
- 102 sitesGermany
- Study dates
- 15 Sep 2015to 29 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female adult patients suffering from chronic iron overload receiving an iron chelation therapy
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
102 sites in 1 country.
102 sites in 1 country
Germany102 sites
Novartis Investigative Site
Aachen, North Rhine-Westphalia, 52064
Novartis Investigative Site
Altenburg, 04600
Novartis Investigative Site
Aschaffenburg, Bavaria, 63739
Novartis Investigative Site
Bad Liebenwerda, 04924
Novartis Investigative Site
Bad Mergentheim, 97980
Novartis Investigative Site
Bamberg, Bavaria, 96052
Novartis Investigative Site
Bayreuth, Bavaria, 95445
Novartis Investigative Site
Berlin, 10407
Novartis Investigative Site
Berlin, 10709
Novartis Investigative Site
Berlin, 12487
Novartis Investigative Site
Berlin, 12627
Novartis Investigative Site
Berlin, 13357
Novartis Investigative Site
Berlin, 14089
Novartis Investigative Site
Biberach, 88400
Novartis Investigative Site
Bochum, 44787
Novartis Investigative Site
Bonn, North Rhine-Westphalia, 53177
Novartis Investigative Site
Bottrop, 46236
Novartis Investigative Site
Bremerhaven, 27568
Novartis Investigative Site
Celle, 29221
Novartis Investigative Site
Chemnitz, 09113
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50677
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Donauwörth, 86609
Novartis Investigative Site
Dortmund, North Rhine-Westphalia, 44309
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Dresden, 01127
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Duisburg, North Rhine-Westphalia, 47166
Novartis Investigative Site
Erfurt, Thuringia, 99084
Novartis Investigative Site
Erfurt, 99085
Novartis Investigative Site
Essen, 45136
Novartis Investigative Site
Garbsen, Lower Saxony, 30827
Novartis Investigative Site
Gelsenkirchen, North Rhine-Westphalia, 45879
Novartis Investigative Site
Gera, 07548
Novartis Investigative Site
Goslar, 38642
Novartis Investigative Site
Göttingen, 37073
Novartis Investigative Site
Halle, 06110
Novartis Investigative Site
Hamelin, 31785
Novartis Investigative Site
Hamm, 59063
Novartis Investigative Site
Hanover, 30161
Novartis Investigative Site
Hanover, 30170
Novartis Investigative Site
Heidelberg, 69115
Novartis Investigative Site
Heidenheim, Baden-Wurttemberg, 89518
Novartis Investigative Site
Heilbronn, 74072
Novartis Investigative Site
Herrsching am Ammersee, 82211
Novartis Investigative Site
Hildesheim, 31134
Novartis Investigative Site
Hildesheim, 31135
Novartis Investigative Site
Hof, 95028
Novartis Investigative Site
Iserlohn, Northrhine Westfalia, 58644
Novartis Investigative Site
Kaiserslautern, 67655
Novartis Investigative Site
Kassel, 34119
Novartis Investigative Site
Kassel, 34125
Novartis Investigative Site
Koblenz, 56068
Novartis Investigative Site
Krefeld, 47805
Novartis Investigative Site
Kronach, 96317
Novartis Investigative Site
Landshut, Bavaria, 84028
Novartis Investigative Site
Lemgo, 32657
Novartis Investigative Site
Lübeck, Schleswig-Holstein, 23563
Novartis Investigative Site
Lüdenscheid, 58507
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 68305
Novartis Investigative Site
Marburg, 35037
Novartis Investigative Site
Minden, 32429
Novartis Investigative Site
Moers, 47441
Novartis Investigative Site
Mülheim, 45468
Novartis Investigative Site
München, 81377
Novartis Investigative Site
München, 81479
Novartis Investigative Site
Munich, Bavaria, 80797
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Naunhof, 04683
Novartis Investigative Site
Neuss, 41462
Novartis Investigative Site
Neustadt, 31535
Novartis Investigative Site
Neuwied, Rhineland-Palatinate, 56564
Novartis Investigative Site
Nordhorn, 48527
Novartis Investigative Site
Nuremberg, 90403
Novartis Investigative Site
Nuremberg, 90419
Novartis Investigative Site
Offenburg, 77654
Novartis Investigative Site
Passau, 94036
Novartis Investigative Site
Pirna, Saxony, 01796
Novartis Investigative Site
Porta Westfalica, 32457
Novartis Investigative Site
Potsdam, 14467
Novartis Investigative Site
Regensburg, Bavaria, 93053
Novartis Investigative Site
Remscheid Innen, Northrhine Westfalia, 42859
Novartis Investigative Site
Riesa, 01587
Novartis Investigative Site
Rostock, 18057
Novartis Investigative Site
Rötha, 04571
Novartis Investigative Site
Saarbrücken, 66113
Novartis Investigative Site
Schorndorf, 73614
Novartis Investigative Site
Schwäbisch Hall, 74523
Novartis Investigative Site
Speyer, 67346
Novartis Investigative Site
Stade
Novartis Investigative Site
Stolberg, 52222
Novartis Investigative Site
Stuttgart, 70178
Novartis Investigative Site
Traunstein, 83278
Novartis Investigative Site
Weiden, 92637
Novartis Investigative Site
Wesel, 46485
Novartis Investigative Site
Westerstede, 26655
Novartis Investigative Site
Winnenden, Baden-Wurttemberg, 71364
Novartis Investigative Site
Wittenberg, 06886
Novartis Investigative Site
Wolfsburg, 38440
Novartis Investigative Site
Würselen, 52146
Novartis Investigative Site
Würzburg, 97080
Novartis Investigative Site
Zittau, Saxony, 02763
About this study
Official title: A Prospective Non-interventional Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload
This is a prospective, multicenter, non-interventional study. Findings are analyzed using epidemiological methods.
Read the 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.
- Conditions
- Chronic Iron Overload
- Being tested
- Iron chelator
- Keywords
- chronic iron overload, Germany, NIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron chelatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Iron chelator | Patients prescribed with Iron Chelators Receives: Other: Iron chelator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of iron overload therapy
Efficiency of iron chelation therapy is evaluated by the change of serum ferritin
Measured: Up to 24 months
Secondary outcomes (7)
Number of patients treated with different iron chelators
Number of patients treated with one of the three iron chelators approved in Germany.
Measured: Up to 24 months
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.
Measured: Up to 24 months
Number of patients with dose adjustments
Number of patients with dose adjustments during the observational period are collected
Measured: Up to 24 months
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
Measured: Up to 24 months
Number of patients with AEs and SAE
Number of patients with Adverse Events and Serious Adverse Events is collected
Measured: Up to 24 months
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.
Measured: Up to 24 months
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start15 Sep 2015
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Iron OverloadStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440487
- Sponsor's protocol ID
- CICL670ADE14
- Acronym
- EXCALIBUR
- Status last verified
- Oct 2022
- First submitted
- 21 Jun 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-interventional Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload
- ClinicalTrials.gov ID
- NCT05440487
- Acronym / sponsor ID
- EXCALIBUR / CICL670ADE14
- Conditions
- Chronic Iron Overload
- Keywords
- chronic iron overload, Germany, NIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron chelator | – | Other: Iron chelatorPatients prescribed with Iron Chelators |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female adult patients suffering from chronic iron overload receiving an iron chelation therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron chelatorThere 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. | Other | Iron chelator |
Primary outcome
Efficiency of iron overload therapy
Time frame: Up to 24 months
Efficiency of iron chelation therapy is evaluated by the change of serum ferritin
7 secondary outcomes
Number of patients treated with different iron chelators
Time frame: Up to 24 months
Number of patients with therapy switch
Time frame: Up to 24 months
Number of patients with dose adjustments
Time frame: Up to 24 months
Number of patients with myelodyplastic syndromes or myeloproliferative neoplasms experiencing a hematologic response during an iron chelation therapy
Time frame: Up to 24 months
Number of patients with AEs and SAE
Time frame: Up to 24 months
Number of patients with side effects
Time frame: Up to 24 months
Treatment Satisfaction Questionnaire to Medication (TSQM) 1.4
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Results for CICL670ADE14 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Iron Overload
Not yet recruitingObservational study
Native T1 Mapping and ECV in Chronic Hemolytic Anemia
Hemolytic Anemia, Thalassemia
Not yet recruitingObservational study
Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathies in Greece.
Thalassemia, Iron Overload
RecruitingObservational study
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Chronic Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
102 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Iron Overload, run by Novartis Pharmaceuticals at 102 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of iron overload therapy (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.