RBR-57qbjv尚未招募2 期
Phase II, randomized clinical trial on the anti-inflammatory effect of Methotrexate associated to Hydroxyurea versus placebo and Hydroxyurea in pediatric patients and young adults with sickle cell disease and vaso-occlusive symptoms
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 8Y 至 30Y（—）
入选标准
- •Sickle Cell Disease patients; aged 08-30 years; patients who have vaso-occlusive pain episodes despite the regular use of hydroxyurea in the clinically-adjusted dose for a period equal or superior to 24 weeks
排除标准
- •Absence of a signed Subject Information and Consent Form/Parents’ or legal guardian’s Informed Permission; renal or hepatic insufficiency; infection at enrollment time; pregnancy or breastfeeding; regular and/or frequent blood transfusions; refusal of contraceptive measures by females in reproductive age
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