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

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Novartis

Status

Completed

Conditions

Chronic Iron Overload

Treatments

Other: Iron chelator

Study type

Observational

Funder types

Industry

Identifiers

NCT05440487
CICL670ADE14

Details and patient eligibility

About

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

Full 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.

Enrollment

489 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

-

Trial design

489 participants in 1 patient group

Iron chelator
Description:
Patients prescribed with Iron Chelators
Treatment:
Other: Iron chelator

Trial contacts and locations

103

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Data sourced from clinicaltrials.gov

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