Status:
COMPLETED
Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Severe Cardiac Iron Overload
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cardiac Iron Overload
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed be deferasirox monotherapy in patients with severe iron overload due to chronic blood transfus...
Eligibility Criteria
Inclusion
- Patients with β-thalassemia major or Diamond-Blackfan anemia (DBA) or congenital sideroblastic anemia on chronic transfusion therapy
- Myocardial T2\* value that is ≥ 5 and \< 10 ms
- Left ventricular ejection fraction (LVEF) ≥ 56% as determined by Magnetic resonance imaging (MRI)
- Liver Iron Concentration (LIC) ≥ 7 mg Fe /g dw as determined by R2 MRI.
- Lifetime history of at least 50 units of red blood cell transfusions, and must be receiving at least ≥ 8 units/yr of red blood cell transfusions
- Serum ferritin ≥ 1000 ng/mL
Exclusion
- Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)
- Patients unable to undergo study assessments including MRI
- Patients with serum creatinine greater than Upper limit of normal ULN)range or with significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) ≥1.0 mg/mg in a non-first void urine sample at baseline.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01254227
Start Date
January 1 2011
End Date
November 1 2013
Last Update
July 26 2021
Active Locations (15)
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1
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2C4
2
Novartis Investigative Site
Cairo, Egypt
3
Novartis Investigative Site
Athens, GR, Greece, GR-115 27
4
Novartis Investigative Site
Patra - RIO, GR, Greece, 265 04