CTRI/2023/01/049275进行中（未招募）2 期
A multicentre trial evaluating the efficacy and safety of oral decitabine-tetrahydrouridine (NDec) in patients with sickle cell disease - ASCENT 1 (NN7533-4470)
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •1. Age above or equal to 18 years at the time of signing informed consent
- •2. Confirmed diagnosis of SCD (including HbSS, HbSC, HbSß0 thalassaemia and HbSß+ thalassaemia)
- •3. 2-10 episodes of documented vaso-occlusive crisis (VOCs) within the last 12 months prior to the screening visit
- •4. Haemoglobin greather than or equal to 5.0 g/dL and below or equal to 10.5 g/dL at visit 1
- •5. Reticulocyte count greater than1.5 x upper limit of the normal (ULN) at visit 1
- •6. Body weight 40 to 125 kg (inclusive)
排除标准
- •1. 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.
- •2. Receipt of erythropoietin or other haematopoietic growth factor treatment within 28 days of signing ICF, or planned treatment with these agents during the trial.
- •3. 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.
- •4. Platelet count greater than 800 multiply 10000000000 per L at visit 1.
- •5. Absolute neutrophil count below 1.5 multiply 10000000000 per L at visit 1.
- •6. Female who is pregnant, breast-feeding or intends to become pregnant within 6 months after the final trial product administration or is of child-bearing potential and not using highly effective methods of contraception -or adequate contraceptive measures as required by local regulation or practice- starting at screening and throughout the trial period and for 6 months after the last dose of trial product.
- •7. Male of reproductive age 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 - or adequate contraceptive measure as required by local regulation or practice- from trial start to:
- •a. Six months after the last dose of trial product for patients on NDec or Placebo.
- •b. Six months after the last dose of trial product for patients outside US and CA randomised to HU.
- •c. Twelve months after the last dose of trial product for patients randomised to HU in US and CA.
研究者
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