A prospective single arm study to assess the efficacy and safety of deferasirox 20 mg/kg BID in transfusion dependent beta-thalassemia patients unresponsive to current treatment with doses > 35 mg/kg QD or with intolerance to single dose therapy

ovartis0 个研究点目标入组 40 人开始时间: 待定最近更新: 2018年2月22日

适应症

试验速览

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•Inclusion: Aged 2 years; Serum ferritin >2000 ng/ml and unresponsive to current treatment with doses > 35 mg/kg QD (decrease in ferritin level less than 10%); patients who did not tolerate single dose therapy due to adverse effects
•Exclusion: Patients will be excluded from this trial if they have one of the following criteria: positive serology for HBS Ag , HCV Ab, HIV Ab. Abnormal liver or kidney function tests;An alanine aminotranferase (ALT) level greater than 250 U/L;serum creatinine level above the upper limit of normal, and a urinary protein-creatinine ratio of greater than 0.5 mg/mg); a history of ocular toxicity related to iron chelation therapy;uncontrolled systemic hypertention, a prolonged corrected QT interval; systemic infection within 10days prior to enrollment; gastrointestinal absorption problem ;Patients who found complication of chelation therapy during trial as well as breast feeding and pregnant women.

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