NCT02515838已完成2 期
A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in Subjects With Sickle-Cell Disease (SCD).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 20
- 主要终点
- Time to resolution of VOC
研究概览
简要总结
A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in Subjects with Sickle-Cell Disease (SCD).
详细描述
This will be a phase II, multi-centre, randomized, double-blind, placebo-controlled study designed to assess preliminary efficacy, safety and pharmacokinetics (PK) of 2-7 days continuous IV administration of sevuparin for the management of acute VOC in subjects with SCD.
Adults and adolescents ≥ 12 years of age will be randomized to treatment with sevuparin or placebo (ratio 1:1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign a written informed consent (adults, parents) and assent (adolescents)
- •Male or female, age 12-50 years.
- •Diagnosis of Sickle cell disease
- •Subjects admitted for an acute, painful VOC to be treated/or treated with parenteral opioid analgesia.
- •Expectancy of need for hospitalization during at least 48 hours.
- •Be at least 1 year postmenopausal, surgically sterile, or if Women of Child Bearing Potential (WOCBP), e.g. following menarche practicing an effective method of birth control
排除标准
- •Severe hepatic failure/disease, abnormal liver enzyme tests or history of hepatitis B virus (HBV), hepatitis C virus (HCV)
- •Abnormal conjugated (direct) bilirubin 3 fold above ULN
- •History of clinically significant bleeding in vital organs
- •Current clinically significant bleeding, as judged by the investigator
- •Current use of acetylsalicylic acid (ASA), anti-platelet therapy, anticoagulant therapy
- •Abnormal coagulation laboratory values
- •A platelet count <75,000/µL.
- •Subjects with more than 5 hospitalizations for VOC during the last 6 months
- •Evidence of acute SCD complications other than VOC at screening
- •The use of strong opioids for > 3 consecutive days during the last 15 days before presenting to the hospital
- •History of chronic drug abuse.
- •Renal dysfunction
- •Known infection (positivity) with human immunodeficiency virus (HIV), HBV or HCV.
- •Significant ECG abnormality
- •History of a clinically significant drug allergy to heparin, LMWH's, sevuparin, or morphine.
- •Use of any investigational agent during the 30 days prior to the first dose.
- •For females: pregnancy, lactating or intention of becoming pregnant
- •Evidence of clinically significant disorders that might interfere with the study aim or safety of the subject
- •Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo infusion
干预措施: Placebo (Other)
Sevuparin
Experimental
Sevuparin infusion
干预措施: Sevuparin (Drug)
结局指标
主要结局
Time to resolution of VOC
时间窗: From hospitalisation until discharge, defined as freedom from parenteral opioid use and readiness for discharge i.e. from randomisation until day 7
Time from start of infusion until resolution of VOC crisis/episode
次要结局
- Cumulative dose of parenteral opioids(From baseline (visit 1) until day 3-7)
- Duration of severest pain,(From baseline (visit 1) until day 3-7)
- Frequency and pattern of treatment-emergent adverse event (TEAEs)(Time from start randomsiation until end of study, approximately 1 month 1 week after randomisation)
- Pharmacokinetic (PK) characteristics of sevuparin(Pre dose, 1h, 2h, 24h, 1/day (day 3-8))
- Mean change in pain intensity(From baseline (visit 1) until day 3-7)
研究者
研究点 (20)
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