EUCTR2014-005420-10-GB进行中（未招募）1 期
A randomised, double-blind, double-dummy, parallel-group, multicenter, phase IIb study to evaluate the effect of ticagrelor 10 mg and 45 mg bid versus placebo in reducing the number of days with pain in young adults with sickle cell disease. - Young Adult SCD Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 87
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
- •1. Male and female young adults aged = 18 to = 30 years inclusive, diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/ß0).
- •2. If treated with an anti-sickling agent such as hydroxyurea, dose must be stable for 3 months before enrolment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients should have low risk for haemorrhagic events, no significant hepatic impairment or renal failure requiring dialysis and low risk of bradycardic events.
- •2. No concomitant oral or intravenous therapy with strong CYP3A4 (cytochrome) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers.
- •3. No surgical procedure planned to occur during the study.
- •4. Patients who are currently pregnant or breastfeeding or planning to become pregnant during the study.
- •5. Patients who have known hypersensitivity or contraindication to ticagrelor.
研究者
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