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临床试验/EUCTR2014-005685-30-GB
EUCTR2014-005685-30-GB进行中(未招募)1 期

ong-term safety and efficacy study of Ferriprox® for the treatment of transfusional iron overload in patients with sickle cell disease or other anemias. - FIRST (Ferriprox in patients with iron overload in sickle cell disease trial)

ApoPharma Inc.0 个研究点目标入组 300 人开始时间: 2015年7月20日最近更新:
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
300

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

入选标准

  • Completed study LA38-0411.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 5
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 5
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • 1. Plan to participate in another clinical trial at any time from the day of enrollment until 30 days post-treatment in the current study.
  • 2. For only those patients who were treated with deferoxamine in study LA38-0411 (Group 2): Presence of any medical condition (including clinically significant laboratory abnormalities, such as ALT = 5 x ULN or creatinine = 2 x ULN), psychological condition, or psychiatric condition which in the opinion of the investigator would cause participation in the study to be unwise.
  • 3. Pregnant, breastfeeding, or planning to become pregnant during the study period.
  • 4. Treatment failure after 1 year on deferiprone which in the investigator’s judgment indicates the need for the patient to be started on a different iron chelator.

研究者

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