PACTR202407870029422尚未招募1 期
Phase I and II open, controlled and randomized clinical trial of Faca® pediatric syrup for the management of children with sickle cell disease from 06 months to 5 years of age
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •Must not have sickle cell disease or sickle cell trait (hemoglobin AA on electrophoresis);
- •No renal or hepatic impairment;
- •Must be at least 06 months and no more than 57 months old;
- •Parents or guardians in charge of the child who have signed the informed consent form;
- •Be able to take FACA® Pediatric Syrup orally;
- •Reside in the study area (Ouagadougou)
排除标准
- •Known allergies to study drugs or any of their components;
- •Participation in any other ongoing clinical study
- •Participant undergoing another treatment for sickle cell disease at the time of the trial;
- •Refusal to sign informed consent by parents or guardians;
- •Participant presenting signs of severity (chronic complications, stroke, acute chest syndrome, etc.).
- •Participant with severe neurological and/or mental disorders;
- •Patient suffering from any other serious pathologies
研究者
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