NL-OMON52956招募中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 hydroxyureal/hydroxycarbamide therapy, in adolescent and adult sickle cell disease patients with vaso-occlusive crises (STAND) - CSEG101A2301 - STAND
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 12
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
- 年龄范围
- 16 至 99（—）
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.
- •3. Confirmed diagnosis of SCD by Hb electrophoresis or HPLC (performed
- •locally). All SCD genotypes are eligible, genotyping is not required for study
- •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 resolve at least 7 days prior to Week 1 Day 1 and must
- •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
- •antiinflammatory drug (NSAID) analgesia,
- •Acute chest syndrome (ACS), priapism and hepatic or splenic sequestration will
- •be considered VOC in this study.
- •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
- •* 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 Schwartz 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
- •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.
- •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
- •8. Not able to understand and to comply with study instructions and
- •requirements.
研究者
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