EUCTR2006-002102-57-DE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
适应症
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
- 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 = 300µg/L and = 2000 µg/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 <13 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 = 2x 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
- •Illicit drug use and/or alcohol use, defined as no more than one drink a day for women, and no more than two drinks a day for men within the 12 months prior to enrolement. A standard drink is generally considered to be 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of 80-proof distilled spirits
- •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 with a known diagnosis of cirrhosis (confirmed by biopsy if available)
研究者
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