Transfusional Hemosiderosis Clinical Trial
Official title:
International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting
This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.
Status | Completed |
Enrollment | 120 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Egypt | Novartis Investigative Site | Cairo | |
Egypt | Novartis Investigative Site | Cairo | |
Jordan | Novartis Investigative Site | Amman | |
Spain | Novartis Investigative Site | Barcelona | Cataluña |
Spain | Novartis Investigative Site | Barcelona | Cataluña |
Spain | Novartis Investigative Site | Oviedo | Asturias |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | West Midlands | Birmingham |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Egypt, Jordan, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum Creatinine and liver enzyme levels | Observed over 3 years for each patient | 3 years | Yes |
Primary | Adverse Drug Reactions | Observed over 3 years for each patient | 3 years | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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