Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Rare Chronic Anemia Patients
NCT ID: NCT00303329
Last Updated: 2011-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
184 participants
INTERVENTIONAL
2004-03-31
2008-10-31
Brief Summary
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The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Deferasirox
Deferasirox daily oral dose between 5-40 mg/kg/day
Deferasirox
Deferasirox available as 125 mg, 250 mg or 500 mg tablets
Interventions
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Deferasirox
Deferasirox available as 125 mg, 250 mg or 500 mg tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients who have reached menarche and who are sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation
* Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation
Exclusion Criteria
2 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Children's Hospital and Research center at Oakland
Oakland, California, United States
Stanford Hospital
Stanford, California, United States
Childres's Hospital Boston
Boston, Massachusetts, United States
New York Presbyterian Hospital
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Bruges, , Belgium
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
La Louvière, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Montreal, , Canada
Novartis Investigative Site
Toronto, , Canada
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Le Kremlin-Bicêtre, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Troyes, , France
Novartis Investigative Site
Düsseldorf, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Brindisi, , Italy
Novartis Investigative Site
Cagliari, , Italy
Novartis Investigative Site
Genova, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Pavia, , Italy
Novartis Investigative Site
Rome, , Italy
Novartis Investigative Site
Torino, , Italy
Novartis Investigative Site
London, , United Kingdom
Countries
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Other Identifiers
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CICL670A0108E1
Identifier Type: -
Identifier Source: org_study_id
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