A phase III, Multicenter, Randomized, Double-blind Study toAssess Efficacy and Safety of Two Doses of Crizanlizumabversus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult SickleCell Disease Patients with Vaso-Occlusive Crises (STAND)

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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.

发起方

ovartis Healthcare Pvt Ltd