Status:
COMPLETED
Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-transfusion Dependent Thalassemia
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief 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 treatmen...
Eligibility Criteria
Inclusion
- Core
- Male or female aged ≥ 10 years with non-transfusion dependent syndromes, not requiring transfusion within 6 months prior to study start. Note: there was a local country amendment for Greece only to change the age specific inclusion criteria to ≥ 18 years old
- Liver iron concentration ≥ 5 mg/g dry weight measured by Magnetic resonance imaging (MRI) before study start
- Serum ferritin \>300 ng/mL at screening
- Core
Exclusion
- Hemoglobin S (HbS)-variants of thalassemia syndromes
- Anticipated regular transfusion program during the study. Patients having a sporadic transfusion (e.g. in case of infection) throughout the study course will not be excluded
- Any blood transfusion 6 months prior to study start
- Creatinine clearance ≤ 60 mL/min at screening
- Serum creatinine above the upper limit of normal at both screening visits
- Significant proteinuria as indicated by a urine protein/urine creatinine ratio \> 1.0 mg/mg
- Alanine aminotransferase (ALT) of \> 5 x the upper limit of normal at both screening visits
- Concomitant therapy with hydroxyurea, erythropoietin, butyrate
- History of deferasirox treatment
- Pediatric patients: a patient's weight of below 20 kg
- Extension Inclusion Criteria:
- Patients who completed the core CICL670A2209 clinical trial
- Written informed consent obtained prior entry to one year extension study CICL670A2209
- Extension
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00873041
Start Date
November 1 2008
End Date
June 1 2012
Last Update
July 9 2013
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609-1809
2
Children's Memorial Hospital/Division of Hematology/Oncology
Chicago, Illinois, United States, 60614-3394
3
New York Presbyterian Hospital/Weill Medical College of Cornell University
New York, New York, United States, 10021
4
Novartis Investigative Site
Athens, Greece