EUCTR2014-004416-11-BE进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 133
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Sign a written informed consent (adults, parents) and assent (adolescents).
- •2. Male or female, age 12-50 years.
- •3. Diagnosis of Sickle cell disease, types HbSS, HbSC, Hb O Arab, HbSß0-thalassemia or HbSß+-thalassemia (SCD type to be confirmed by liquid chromatography or other method of comparable reliability during the study, if confirmation is not available at time of inclusion)
- •4. Subjects admitted for an acute, painful VOC to be treated/or treated with parenteral opioid analgesia at the time of admission. VOC is defined as an episode of pain that led to a clinic or emergency department visit, and cannot be explained except by SCD. Please note: Study treatment should start as soon as possible and at latest within 24 hours from the time of the decision to hospitalize the subject.
- •5. Expectancy of need for hospitalization during at least 48 hours.
- •6. Be at least 1 year postmenopausal, surgically sterile, or if WOCBP, e.g. following menarche practicing an effective method of birth control (e.g. oral contraception, intrauterine device, or diaphragm with spermicide; or double barrier method) during study drug administration and one month following treatment completion.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 93
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Severe hepatic failure/disease or liver enzyme tests (AST and ALT) above 2 times the upper limit of normal (ULN) range, or clinically significant impairment of liver function due to HBV, HCV or other liver diseases.
- •2. Conjugated (direct) bilirubin 3 fold above ULN.
- •3. History of clinically significant bleeding in vital organs (not due to relevant trauma), or pathological bleeding.
- •4. Current clinically significant bleeding, as judged by the investigator.
- •5. Current use of ASA, anti-platelet therapy, anticoagulant therapy and prophylactic and therapeutic LMWH or un-fractioned heparin.
- •6. APTT above normal range , and INR above 1.4.
- •7. A platelet count < 75,000/µL.
- •8. BMI >35
- •9. Subjects with more than 5 hospitalizations for VOC during the last 6 months (to exclude subjects with exacerbations of chronic pain rather than true vaso-occlusion).
- •10. Evidence of acute SCD complications other than VOC at screening (CVA, ACS, multi-organ failure).
- •11. The use of strong opioids for > 3 consecutive days during the last 15 days before presenting to hospital.
- •12. History of chronic drug abuse.
- •13. Renal dysfunction (GFR< 60 ml/min), calculated per Cockcroft-Gault formula
- •14. Known infection with HIV, and active infection with HBV or HCV.
- •15. Significant ECG abnormality including QTcf > 450 msec
- •16. History of a clinically significant drug allergy to heparin, LMWH’s or sevuparin.
- •17. Use of any investigational agent during the 30 days prior to the first dose.
- •18. For females: pregnancy, lactating or intention of becoming pregnant within the next 40 days.
- •19. Evidence of clinically significant disorders that might interfere with the study aim or safety of the subject, as judged by the Investigator: e.g. neurological, psychiatric (depression, psychosis or schizophrenia), cardiovascular (including arrhythmia), pulmonary, metabolic, gastrointestinal, endocrine diseases, coagulation or malignancies.
- •20. 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
研究者
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