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Completed

NCT Number: NCT05440487

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.

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Key information

Conditions

Chronic Iron Overload

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Heidenheim, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Iron chelator

Other

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.

Primary outcomes

  1. Efficiency of iron overload therapy

    Time frame: Up to 24 months

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

Secondary outcomes

  1. Number of patients treated with different iron chelators

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 24 months

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

  6. Number of patients with side effects

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: EXCALIBUR

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2022
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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