EUCTR2012-001836-72-BG进行中（未招募）不适用
An Open-label, Randomized, Active Comparator-Controlled, Adaptive Parallel-group Phase 2 Study to Assess the Safety and Efficacy of Multiple Doses of ISIS 416858 Administered Subcutaneously to Patients Undergoing Total Knee Arthroplasty
Isis Pharmaceuticals, Inc.0 个研究点目标入组 400 人开始时间: 2012年12月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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
- 性别
- All
入选标准
- •1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
- •2. Males or Females aged 18 to 80 years old at the time of informed consent
- •3. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion such as bilateral tubal ligation, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal (>12 months since last period). Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the patient must be using an acceptable contraceptive method during and for at least 97 days (approximately 5 half-lives of ISIS 416858) after the last dose of Study Drug.
- •4. Undergoing elective, primary unilateral total knee arthroplasty
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Body weight <50 kg at Screening
- •2. VTE within the past year
- •3. Malignancy within 1 year, except for basal or squamous cell carcinoma
- •of the skin or carcinoma in situ of the cervix that has been successfully
- •4. Myocardial infarction, transient ischemic stroke or stroke within the
- •last 6 months
- •5. Patients at increased risk of bleeding because of history of increased
- •bleeding tendency or any other condition that in the opinion of the
- •investigator increases risk of bleeding (e.g., documented angiodysplasia,
- •recurrent gastrointestinal ulcer). History of intracranial or intraocular
- •bleeding. History of gastrointestinal bleeding and/or endoscopically
- •verified ulcer disease within the past year.
- •6. History of a traumatic spinal or epidural anesthesia or excessive intraor
- •direct post operative bleeding
- •7. Brain, spinal, or ophthalmologic surgery within the past 3 months
- •8. Cockcroft-Gault calculated GFR <60 mL/min at Screening
- •9. History of clinically significant liver disease in the past year
- •10. Screening laboratory results as follows, or any other clinically
- •significant abnormalities in screening laboratory values that would
- •render a patient unsuitable for inclusion
- •Urine protein or blood persistently positive by dipstick. In the event of
- •positive test results, eligibility may be confirmed with urine microscopy
- •or 24 hour urine protein measurement as applicable
- •ALT or AST >1.5 x ULN
- •Total bilirubin >ULN
- •Platelet count <150,000 (or history of thrombocytopenia)
- •Factor IX activity •Factor VIII activity, vWF antigen or Ristocetin cofactor activity <0.5
- •FXI activity <0.3 U/mL
- •11. Uncontrolled hypertension as judged by the Investigator
- •12. Hypersensitivity to contrast media
- •13. Hypersensitivity to enoxaparin or any contraindication listed in the
- •local labeling of enoxaparin
- •14. Anticipated concomitant use of anticoagulants/antiplatelet agents
- •(e.g., dabigatran, rivaroxaban, clopidogrel) or the NSAID nimesulide that
- •may affect study outcome or any other drug influencing coagulation
- •(except low dose aspirin and short acting NSAIDs with a half-life <20
- •hours) at least 7 days before surgery or during treatment with ISIS
- •15. Treatment with another investigational Drug, biological agent, or
- •device within one month of screening, or 5 half-lives of study agent,
- •whichever is longer
- •16. Treatment with any non-ISIS oligonucleotide (including siRNA) at
- •any time or prior treatment with an ISIS oligonucleotide within 9
- •months of screening. Patients that have previously received only a
- •single dose of an ISIS oligonucleotide as part of a clinical study may be
- •included as long as a duration =4 months elapsed since dosing
- •17. Recent history of, or current drug or alcohol abuse
- •18. Active infection (e.g., endocarditis, sepsis) requiring systemic
- •antiviral or antimicrobial therapy
- •19. Anticipated use of indwelling intrathecal or epidural catheters
- •20. Anticipated use of intermittent pneumatic compression devices and
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