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Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01394029
Enrollment
120
Registered
2011-07-14
Start date
2011-07-31
Completion date
2015-10-31
Last updated
2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusional Hemosiderosis

Keywords

iron overload, iron chelation, deferasirox, observational

Brief summary

This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.

Interventions

DRUGdeferasirox

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

Inclusion criteria

-Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information. (the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.

Exclusion criteria

* Patients with non-transfusional hemosiderosis * Patients treated with deferasirox in an interventional clinical trial Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Serum Creatinine and liver enzyme levels3 yearsObserved over 3 years for each patient
Adverse Drug Reactions3 yearsObserved over 3 years for each patient

Countries

Egypt, Jordan, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026