EUCTR2009-012418-38-DK进行中（未招募）不适用
A multi-center, randomized, double-blind, placebo-controlled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload (TELESTO) - TELESTO
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
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 , =18 years of age, 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.
- •Weight between 35-135 kg
- •Ferritin > 1000 mcg/L at screening
- •History of transfusion of 15 to 75 pRBC units
- •Anticipated to be transfused with at least 8 units of PRBCs 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
- •Additional inclusion criteria as per full protocol may apply.
- •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 6 months of cumulative iron chelation therapy (such as daily
- •deferasirox (Exjade®) or deferiprone or 5×/week deferoxamine)
- •- Intermittent deferoxamine doses in association with blood
- •transfusions are not exclusionary regardless of duration of such
- •More than 3 years since patient began receiving regular transfusions
- •(2 units per 8 weeks or 4 units received in a 3 month period)
- •Creatinine Clearance <40 ml/min
- •Serum creatinine > 1.5 × ULN at screening
- •- Serum creatinine will be measured at Screening Visit 1 and Screening
- •Visit 2 (at least 14 days apart) and the mean value will be used for
- •eligibility criteria.
- •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 < 50% by echocardiography as per
- •the central reading assessment
- •A history of hospitalization for congestive heart failure
- •Systemic diseases which would prevent study treatment (e.g.
- •uncontrolled hypertension, cardiovascular, renal, hepatic (including
- •Child-Pugh Class B and C), 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
- •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 > 3.5 × ULN at screening
- •Total bilirubin > 1.5 × ULN at screening
- •Diagnosis of liver cirrhosis (either established diagnosis or diagnosis
- •by liver biopsy or central ultrasound reading)
- •Patients participating in another clinical trial other than an
- •observational registry study
- •Patients with a history of another malignancy within the past five
- •years, with the exception of basal skin carcinoma or cervical carcinoma
- •in situ or completely resected colonic polyps 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, or breast-feeding patients, or patients of child-bearing
- •potential not employing an effective method of birth control (see Women
- •of child-bearing potential, below, for further details regarding effective
- •methods of birth control).
- •History of drug or alcohol abuse within the 12 months prior to
- •Additional exclusion criteria as per full protocol may apply.
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