NCT00873041

Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Non-transfusion Dependent Thalassemia

Interventions

Type	Name	Description
DRUG	deferasirox	Supplied as 125 mg, 250 mg and 500 mg tablets.
DRUG	placebo	Supplied as matching 125 mg, 250 mg and 500 mg tablets.

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-06-01
• Completion: 2012-06-01
• First posted: 2009-04-01
• Last updated: 2013-07-09
• Results posted: 2012-09-25

Locations

21 sites across 9 countries: United States, Greece, Italy, Lebanon, Malaysia, Taiwan, Thailand, Turkey (Türkiye), United Kingdom