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Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394029
First Posted: July 14, 2011
Last Update Posted: February 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.

Condition Intervention
Transfusional Hemosiderosis Drug: deferasirox

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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


Enrollment: 120
Study Start Date: July 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
deferasirox Drug: deferasirox
Other Name: ICL670

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394029


Locations
Egypt
Novartis Investigative Site
Cairo, Egypt, 11566
Novartis Investigative Site
Cairo, Egypt
Jordan
Novartis Investigative Site
Amman, Jordan, 11195
Spain
Novartis Investigative Site
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08916
Novartis Investigative Site
Barcelona, Cataluña, Spain
United Kingdom
Novartis Investigative Site
West Midlands, Birmingham, United Kingdom, B4 6NH
Novartis Investigative Site
London, United Kingdom, N18 1QX
Novartis Investigative Site
London, United Kingdom, N19 5NF
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01394029     History of Changes
Other Study ID Numbers: CICL670A2301
First Submitted: July 12, 2011
First Posted: July 14, 2011
Last Update Posted: February 2, 2016
Last Verified: February 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
iron overload
iron chelation
deferasirox
observational

Additional relevant MeSH terms:
Hemosiderosis
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Deferasirox
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action