EUCTR2006-002102-57-IT进行中（未招募）不适用
A phase I/II open label, dose escalation trial to explore the safety and efficacy of ICL670 in patients with iron overload resulting from hereditary hemochromatosis - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
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
- •Age >= 18 years ? Male or female patients homozygous for the C282Y mutation documented by molecular diagnostic testing. ? Serum ferritin value >= 300?g/L and <= 1500 ?g/L with a transferrin saturation >=45%. ? No known allergy or contraindication to the administration of deferasirox ? Ability to comply with all study-related procedures, medications, and evaluations ? 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. Postmenopausal is defined by amenorrhea for at least 12 months.
- •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
- •Iron overload not due to hereditary hemochromatosis ? History of blood transfusion during the 6 months prior to study entry ? Males with hemoglobin <14 mg/dL, females with hemoglobin <12 mg/dL ? Treatment with phlebotomy within 2 weeks of screening visit ? Desferal treatment within 1 month of the screening visit ? Patients currently or previously treated with deferiprone or deferasirox (ICL670) ? Patients with serum creatinine > upper limit of normal ? Patients with ALT >= 3x ULN at screening ? Significant medical condition interfering with the ability to partake in this study ? Presence of a surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any study drug ? Clinical evidence of active Hepatitis B (positive HBsAg with negative HBsAb) or hepatitis C (positive HCV antibody and detectable HCV RNA with ALT above the normal range) ? Positive HIV serology ? Patients with active inflammatory diseases that may interfere with the accurate measurement of serum ferritin ? Patients with a diagnosis of a clinically relevant cataract or a previous history of clinically relevant ocular toxicity related to iron chelation ? History of drug or alcohol abuse within the 12 months prior to enrollment ? Pregnant or breast feeding patients ? Patients treated with systemic investigational drug within 4 weeks prior or with topical investigational drug within 7 days prior to the screening visit Patients who are found to be ineligible after screening procedures will have this documented in the case report form (CRF). These patients will not need to complete the end of study assessments.
研究者
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