Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study
Completed · Phase 2 · Has a placebo group
Conditions studied: Non-transfusion Dependent Thalassemia
In brief
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).
Key facts
- Study ID
- NCT00873041
- Run by
- Novartis Pharmaceuticals
- People needed
- 166
- Starts
- 2008-11-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2013-07-09
Who can join
Age: 10 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Novartis Investigative Site — Rome, Italy
- Novartis Investigative Site — Beirut, Lebanon
- Novartis Investigative Site — Ampang Selangor, Malaysia
- Novartis Investigative Site — Kuala Lumpur, Malaysia
- Novartis Investigative Site — Taipei, Taiwan
- Novartis Investigative Site — Bangkok, Thailand
- Novartis Investigative Site — Adana, Turkey (Türkiye)
- Novartis Investigative Site — Ankara, Turkey (Türkiye)
- Novartis Investigative Site — Istanbul, Turkey (Türkiye)
- Novartis Investigative Site — Izmir, Turkey (Türkiye)
- Novartis Investigative Site — London, United Kingdom
Full record on ClinicalTrials.gov
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