NCT05440487

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 489 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Iron Overload

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-15
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2022-06-30
• Last updated: 2022-10-21

Locations

102 sites across 1 country: Germany