Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

• Register: ClinicalTrials.gov
• Last refreshed on: 15 February 2016
• Main ID: NCT01394029
• Date of registration: 12/07/2011
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox
• Scientific title: International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting
• Date of first enrolment: July 2011
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01394029
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

Egypt, Jordan, Spain, United Kingdom

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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.



Age minimum: 2 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Transfusional Hemosiderosis

Intervention(s)

Drug: deferasirox

Primary Outcome(s)

Serum Creatinine and liver enzyme levels [Time Frame: 3 years]

Adverse Drug Reactions [Time Frame: 3 years]

Secondary ID(s)

CICL670A2301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors