A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - ND

OVARTIS FARMA0 个研究点目标入组 192 人开始时间: 2008年1月8日最近更新: 2013年4月15日

适应症

试验速览

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•Age ≥10 years. Male or female patients with β-thalassemia major or DBA or sideroblastic anemia on chronic transfusion therapy, having given written consent to participate in the study. Myocardial T2* value that is ≥ 10 but not >20 ms. Lifetime history of at least 50 units of red cell transfusions, and must be receiving at least ≥10 units/yr of red blood cells transfusions. LVEF ≥ 56 % as determined by CMR. LIC ≥ 3 mg Fe / g dw, as determined by liver MRI. Patients on prior chelation therapy with deferoxamine (DFO, Desferal), deferasirox (ICL670, Exjade) or deferiprone (L1, Ferriprox) or a combination of DFO and L1 will be enrolled. Patients will undergo a 2-day washout period prior to commencing study treatment.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients with clinical symptoms of cardiac dysfunction. Patients unable to undergo study assessments including MRI: Are claustrophobic to MRI. Have a pacemaker, ferromagnetic metal implants other than those approved as safe for use in MRI scanners (e.g., some types of aneurysm clips, shrapnel in proximity to vital organs such as the retina). Are obese (exceeding the equipment limits). Patients with serum creatinine > ULN or with significant proteinuria as indicated by a urinary protein/creatinine ratio ≥ 1.0 in a non-first void urine sample at baseline. Patients with ALT (SGPT) levels > 5 x ULN. Patients with considerable impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox / ICL670 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). History of clinically relevant ocular and/or auditor toxicity related to iron chelation therapy. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent or undergoing any of the treatment options or patients unwilling or unable to comply with the protocol. Patients with a known history of HIV seropositivity (Elisa or Western blot). please see protocol

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