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Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

This study is currently recruiting participants.
Verified November 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01394029
First received: July 12, 2011
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  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:

MedlinePlus related topics: Iron
Drug Information available for: Deferasirox
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Serum Creatinine and liver enzyme levels [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Observed over 3 years for each patient

  • Adverse Drug Reactions [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Observed over 3 years for each patient


Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
deferasirox
deferasirox
 Drug: deferasirox
Other Name: ICL670

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394029

Contacts
Contact: Novartis Pharmaceuticals +1(800)340-6843

Locations
Jordan
Novartis Investigative Site Recruiting
Amman, Jordan
United Kingdom
Novartis Investigative Site Not yet recruiting
London, United Kingdom, SE5 8AD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01394029     History of Changes
Other Study ID Numbers: CICL670A2301
Study First Received: July 12, 2011
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Jordan: Ethical Committee
Egypt: Ministry of Health, Drug Policy and Planning Center

Keywords provided by Novartis:
iron overload
iron chelation
deferasirox
observational

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

ClinicalTrials.gov processed this record on May 23, 2013