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
1 other identifier
observational
120
4 countries
10
Brief Summary
This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2011
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 2, 2016
February 1, 2016
4.3 years
July 12, 2011
February 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Serum Creatinine and liver enzyme levels
Observed over 3 years for each patient
3 years
Adverse Drug Reactions
Observed over 3 years for each patient
3 years
Study Arms (1)
deferasirox
Interventions
Eligibility Criteria
Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.
You may qualify if:
- 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.
You may not qualify if:
- Patients with non-transfusional hemosiderosis
- Patients treated with deferasirox in an interventional clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Novartis Investigative Site
Cairo, Cairo Governorate, 11566, Egypt
Novartis Investigative Site
Cairo, Egypt
Novartis Investigative Site
Amman, 11195, Jordan
Novartis Investigative Site
Barcelona, Catalonia, 08916, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, 33006, Spain
Novartis Investigative Site
West Midlands, Birmingham, B4 6NH, United Kingdom
Novartis Investigative Site
London, N18 1QX, United Kingdom
Novartis Investigative Site
London, N19 5NF, United Kingdom
Novartis Investigative Site
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 14, 2011
Study Start
July 1, 2011
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
February 2, 2016
Record last verified: 2016-02