An observational study in Chronic Iron Overload, sponsored by Novartis Pharmaceuticals. Completed at 103 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
This is a prospective, multicenter, non-interventional study. Findings are analyzed using epidemiological methods.
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.
156 studies on the registry are indexed under Iron Overload; 6 are open to participants now.
This study's enrollment of 489 is above the median of 94 across 49 observational studies indexed under Iron Overload.
Browse Iron Overload studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male and female adult patients suffering from chronic iron overload receiving an iron chelation therapy
Male and female adult patients suffering from chronic iron overload
Exclusion Criteria:
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Efficiency of iron overload therapy
Efficiency of iron chelation therapy is evaluated by the change of serum ferritin
Time frame: Up to 24 months
Number of patients treated with different iron chelators
Number of patients treated with one of the three iron chelators approved in Germany.
Time frame: 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.
Time frame: Up to 24 months
Number of patients with dose adjustments
Number of patients with dose adjustments during the observational period are collected
Time frame: 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
Time frame: Up to 24 months
Number of patients with AEs and SAE
Number of patients with Adverse Events and Serious Adverse Events is collected
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months
Showing the first 100 of 103 sites. Choose a country and city above to see the rest.
Plan to share: No
Ran from Sep 2015 to primary completion in Oct 2021, 73 months.
Of 13 observational studies under Iron Overload, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's 73 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.