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A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Efficacy and Safety of Deferasirox in Non-transfusion-dependent Thalassemia Patients With Iron Overload
CICL670A2209: This study will evaluate the safety and efficacy of deferasirox in non-transfusion dependent thalassemia patients with iron overload. Patients will be treated either with active treatment (deferasirox) or placebo for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study with the active treatment (deferasirox) in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the liver will be evaluated using magnetic resonance imaging (MRI) assessments. CICL670A2209E1: A one-year open-label extension to a randomized, double-blind, placebo-controlled, phase II study to evaluate efficacy and safety of deferasirox in non-transfusion dependent thalassemia patients with iron overload (Thalassa).
Age
10 - No limit years
Sex
ALL
Healthy Volunteers
No
Children's Hospital & Research Center Oakland
Oakland, California, United States
Children's Memorial Hospital/Division of Hematology/Oncology
Chicago, Illinois, United States
New York Presbyterian Hospital/Weill Medical College of Cornell University
New York, New York, United States
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Pátrai, Greece
Novartis Investigative Site
Thessaloniki, Greece
Novartis Investigative Site
Cagliari, Italy
Novartis Investigative Site
Genova, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Naples, Italy
Start Date
November 1, 2008
Primary Completion Date
June 1, 2011
Completion Date
June 1, 2012
Last Updated
July 9, 2013
166
ACTUAL participants
deferasirox
DRUG
placebo
DRUG
Lead Sponsor
Novartis Pharmaceuticals
Data Source & Attribution
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