At a glance
ClinicalIndex Comparison Record- ✓Completion of the 12-month core study (NCT00171171)
- ✓Written informed consent from patient and/or legal guardian
- ✕Pregnant or breastfeeding
- ✕Investigator assessment of unreliability or non-cooperation with study protocol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
1-year Extension to CICL670A2402 an Open-label, Multi-center Trial of the Efficacy and Safety of Long-term Treatment With Deferasirox (10 to 20 mg/kg/Day) in Beta-thalassemia Patients With Transfusional Hemosiderosis (Study Amended to 2- Year Duration)
In Brief
A Phase 4 clinical trial evaluating Deferasirox for Beta-thalassemia Major and 3 related conditions. Completed, enrolled 233 participants across 5 sites in 5 countries.
Detailed Summary
To allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available. To evaluate the long-term safety and efficacy of deferasirox by measuring treatment success, change in liver iron content (LIC) and change in serum ferritin levels. Safety was mainly assessed by incidence of adverse events (AEs)and clinically significant lab parameters.
Study Details
Timeline
Interventions
Deferasirox was administered orally once daily. Deferasirox was available as 125 mg, 250 mg, and 500 mg tablets.