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Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01394029
First received: July 12, 2011
Last updated: October 27, 2014
Last verified: October 2014
  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:

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


Enrollment: 118
Study Start Date: July 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394029

Locations
Egypt
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
Birmingham, United Kingdom, B4 6NH
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Novartis Investigative Site
London, United Kingdom, SE5 8AD
Novartis Investigative Site
London, United Kingdom, N19 5NF
Novartis Investigative Site
London, United Kingdom, N18 1QX
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: October 27, 2014
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 Metabolism Disorders
Iron Overload
Metabolic Diseases
Deferasirox
Chelating Agents
Iron Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents

ClinicalTrials.gov processed this record on November 23, 2014