LBCTR2019060244已完成3 期
A Phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab Versus Placebo, With or Without Hydroxyurea/ Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Vaso-Occlusive Crises (STAND)
ovartis Pharma Services Inc.0 个研究点目标入组 11 人开始时间: 2023年11月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 至 99（—）
- 性别
- All
入选标准
- •1.Written informed consent must be obtained prior to any screening procedures
- •2.Male or female patients aged 12 years and older on the day of signing informed consent. Adolescent include patients aged 12 to 17 years old and adults = 18 years and older
- •3.Confirmed diagnosis of SCD by hemoglobin electrophoresis or high performance liquid chromatography (HPLC) [performed locally]. All SCD genotypes are eligible, genotyping is not required for study entry
- •4.Experienced at least 2 VOCs leading to healthcare visit within the 12 months prior to screening visit as determined by medical history. Prior VOC leading to healthcare visit must include:
- •a.Pain crisis defined as an acute onset of pain for which there is no other medically determined explanation other than vaso- occlusion -
- •b.a visit to a medical facility and/or healthcare professional,
- •c.and receipt of oral/parenteral opioids or parenteral nonsteroidal anti-inflammatory drug (NSAID) analgesia As well as other complicated crises, such as acute chest syndrome, priapism, and hepatic or splenic sequestration
- •5.If receiving HU/HC or erythropoietin stimulating agent or L-glutamine, must have been receiving the drug for at least 6 months prior to Screening visit and plan to continue taking at the same dose and schedule until the subject has reached one year of study treatment
- •6.Patients must meet the following central laboratory values at the screening visit:
- •?Absolute Neutrophil Count =1.0 x 109/L
- •?Platelet count =75 x 109/L
- •?Hemoglobin: for adults (Hb) =4.0 g/dL and for adolescents (Hb) =5.5 g/dL
- •?Glomerular filtration rate = 45 mL/min/1.73 m2 using CKD-EPI formula in adults, and Shwartz formula in adolescents
- •?Direct (conjugated) bilirubin < 2.0 x ULN
- •?Alanine transaminase (ALT) < 3.0 x ULN
- •7.ECOG performance status =2.0 for adults and Karnofsky = 50% for adolescents
排除标准
- •1.History of stem cell transplant.
- •2.Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning on undergoing an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.
- •3.Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
- •4.Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to Screening visit or plans to participate in another investigational drug trial.
- •5.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they are using highly effective methods of contraception during dosing and for 15 weeks after stopping treatment.
- •6.Concurrent severe and/or uncontrolled medical conditions which, in the opinion of the Investigator, could cause unacceptable safety risks or compromise participation in the study.
- •7.History or current diagnosis of ECG abnormalities indicating significant risk of safety such as:
- •?Resting QTcF =470 msec at pretreatment (baseline) for both male and female or inestability to determine QTc
- •?Concomitant clinically significant cardiac arrhythmias (e.g ventricular tachycardia), and clinically significant second or third degree AV block without a pacemaker
- •?History of familial long QT syndrome or know family history of Torsades de Pointes
- •8.Not able to understand and to comply with study intructions and requirements.
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