EUCTR2009-012418-38-IT进行中（未招募）1 期
A multi-center, randomized, double-blind, placebocontrolled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload - TELESTO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 630
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Male or female patients, ≥18 years of age -Patient must weigh between 45-120 kg -Patients with low or intermediate (int-1) risk MDS, as determined by IPSS score. This must be confirmed by a bone marrow examination within 6 months prior to study entry and must be hematologically stable. Ferritin > 1000 mcg/L and < 2500 mcg/L at screening History of transfusion of 20 to 50 PRBC units Chelation-na?ve patients Anticipated to be transfused at least 8 times annually during the study -Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation
- •Are the trial subjects under 18? no
- •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
排除标准
- •-More than 3 years since diagnosis of MDS -Creatinine Clearance <40 ml/min -Serum creatinine > ULN at screening -Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 mg/mg in a non-first void urine sample at Visit 1 or Visit 2 (or alternatively in two of three samples obtained for screening) -ECOG performance status > 2 -Left ventricular ejection fraction < 55% by echocardiography -A history of hospitalization for congestive heart failure -Systemic diseases which would prevent study treatment (e.g.uncontrolled hypertension,cardiovascular, renal, hepatic, metabolic, etc.) -Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range) -History of HIV positive test result (ELISA or Western blot) -Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start ALT or AST > 2.5 ? ULN at screening -Total bilirubin > ULN at screening Diagnosis of liver cirrhosis Patients participating in another clinical trial or receiving an investigational drug -Patients with a history of another malignancy within the past five years, with the exception of basel skin carcinoma or cervical carcinoma in situ. -History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative -Presence of a surgical or medical condition which might significantly alter the absorption,distribution, metabolism or excretion of study drug -Pregnant, intending-to-become pregnant, or breast-feeding patients -History of drug or alcohol abuse within the 12 months prior to enrollment Patients who are found to be ineligible after screening procedures will have this documented on the screening log. These patients will not need to complete the end of study assessments.
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