LBCTR2024015480尚未招募2 期
A multicentre trial evaluating the efficacy and safety of oral decitabine-tetrahydrouridine (NDec) in patients with sickle cell disease
ovo Nordisk0 个研究点目标入组 87 人开始时间: 2024年3月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 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
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •Key inclusion criteria:
- •- Age above or equal to 18 years at the time of signing informed consent
- •- Confirmed diagnosis of SCD (including HbSS, HbSC, HbSß0 thalassaemia and HbSß+ thalassaemia or other Sickle Cell disease variants)
- •- 2–10 episodes of documented VOCs within the last 12 months prior to the screening visit
- •- Haemoglobin =5.0 g/dL and =10.5 g/dL at visit 1
- •- Absolute reticulocyte (absolute) count above ULN at visit 1
- •- Body weight 40 to 125 kg (inclusive)
排除标准
- •Key exclusion criteria:
- •- Patient is on chronic transfusion therapy as defined by receiving scheduled (pre-planned) series of blood transfusion (simple or exchange) for prophylactic purposes, or the patient is likely to begin chronic transfusion therapy during the course of the trial, or has received RBC or whole blood transfusion for any reason within 28 days of visit 1
- •- Receipt of erythropoietin or other haematopoietic growth factor treatment within 28 days of signing ICF, or planned treatment with these agents during the trial
- •- Receipt of voxelotor, crizanlizumab or L-glutamine treatment within 12 weeks of signing the informed consent form, or planned treatment with such agents during the trial
- •- Platelet count >800 x 109/L at visit 1
- •- Absolute neutrophil count =1.5 x 109/L at visit 1
- •- Any condition/concurrent chronic disease involving the stomach or small intestine which may affect drug absorption, as per investigator's judgement
- •- Female who is:
- •- pregnant, breast-feeding or intends to become pregnant within 6 months after the final trial product administration or
- •- child-bearing potential and not using highly effective methods of contraception and whose male partner is not using effective contraception, at screening and until 6 months after the last dose of trial product
- •- Male with female partner of childbearing potential who does not agree to use condom and whose female partner of childbearing potential is not using a highly effective contraceptive measure from trial start to:
- •- Six (6) months after the last dose of trial product for patients on NDec/Placebo
- •- Six (6) months after the last dose of trial product for patients outside US and CA randomised to HU
- •- Twelve (12) months after the last dose of trial product for patients randomised to HU in US and CA
研究者
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