Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

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

Completed

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Key information

Conditions

Transfusional Hemosiderosis Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Cairo, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

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

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/exclusion criteria may apply.

Treatment and study plan

Deferasirox

Drug

Other names: ICL670

Primary outcomes

Serum Creatinine and liver enzyme levels

Time frame: 3 years

Observed over 3 years for each patient
Adverse Drug Reactions

Time frame: 3 years

Observed over 3 years for each patient

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Jul 14, 2011
Registry last updated: Feb 2, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.

Completed