NCT00395629已完成1 期
A Phase I/II Open Label, Dose Escalation Trial and a Six Month Extension to Explore the Safety and Efficacy of ICL670 in Patients With Iron Overload Resulting From Hereditary Hemochromatosis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 10
- 主要终点
- Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)
研究概览
简要总结
Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years of age or older
- •Male or female patients homozygous for the C282Y mutation.
- •Iron overload as documented by serum ferritin and transferrin saturation
- •No known allergy or contraindication to the administration of deferasirox
- •Ability to comply with all study-related procedures, medications, and evaluations
- •Effective use of birth control measures.
排除标准
- •Iron overload not due to hereditary hemochromatosis
- •Males with hemoglobin <13 mg/dL, females with hemoglobin <12 mg/dL
- •Desferal treatment within 1 month of the screening visit
- •Patients currently or previously treated with deferiprone or deferasirox
- •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 or C
- •Positive HIV serology
- •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
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
ICL670 (Deferasirox)
Experimental
Three dose cohorts: 5 mg/kg/day, 10 mg/kg/day, 15 mg/kg/day
干预措施: Deferasirox (ICL670) (Drug)
结局指标
主要结局
Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)
时间窗: 0 to 48 weeks
Mean absolute change in serum ferritin from baseline to the end of the extension study.
次要结局
- Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)(4, 8, 12, 16, 20, and 24 weeks)
研究者
研究点 (10)
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