EUCTR2022-000168-22-FR进行中（未招募）1 期
An open-label, non-comparative, multicentre study to evaluate the acceptability of a new paediatric formulation of hydroxycarbamide in children with sickle cell disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Addmedica
- 入组人数
- 45
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
- •Written informed consent, signed and dated by both parents or by the legally
- •acceptable representative(s) of the children,
- •Child with sickle cell disease, treated with 100 mg and/or 1000 mg Siklos® filmcoated tablets, at the same daily dose for more than 4 weeks,
- •Child aged between 2 and 6 years old,
- •Parents capable of communicating with the investigator and understanding the
- •requirements and constraints of the study protocol and willing to comply with the
- •study requirements,
- •Children affiliated to a social security plan (including universal health coverage) or
- •beneficiary of a similar insurance plan.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participation in any other clinical study for any other pharmaceutical product within
- •4 weeks preceding study inclusion,
- •Known hypersensitivity or allergy to the excipients,
- •Any surgical or medical condition or any significant illness that, in the opinion of
- •the investigator, constitutes a risk or a contraindication to the participation of the
- •patient to the study, or that may interfere with the objectives, conduct or evaluation
- •of the study.
研究者
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