JPRN-jRCT2080223833未知2 期
A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 150
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
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Weight greater than or equal to (>=) 40 kg to less than or equal to (<=) 150 kilogram (kg)
- •- Medically appropriate for postoperative anticoagulant prophylaxis as determined by the investigator
- •- Has undergone an elective primary unilateral total knee replacement (TKR)
- •- Before randomization, a woman must not be of childbearing potential defined as postmenopausal (defined as no menses for 12 months without an alternative medical cause) and/ or permanently sterile (include
- •hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy)
- •- Contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
排除标准
- •- Any condition for which the use of apixaban is not recommended in the opinion of the investigator
- •- Bilateral, revision or unicompartmental procedure
- •- Known or suspected hypersensitivity or intolerance to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or any of the excipients of JNJ-64179375
- •- Unable to undergo venography
- •- Known previous deep vein thrombosis (DVT) in either lower extremity
研究者
相似试验
进行中（未招募）
1 期
A 2-Part Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee ReplacementThromboembolism in subjects who have undergone an elective primary unilateral total knee replacementEUCTR2016-004550-15-LVJanssen-Cilag International NV1,500
进行中（未招募）
1 期
A 2-Part Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee ReplacementThromboembolism in subjects who have undergone an elective primary unilateral total knee replacementEUCTR2016-004550-15-BEJanssen-Cilag International NV1,500
进行中（未招募）
1 期
A 2-Part Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee ReplacementThromboembolism in subjects who have undergone an elective primary unilateral total knee replacementMedDRA version: 20.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865EUCTR2016-004550-15-PTJanssen-Cilag International NV1,500
进行中（未招募）
1 期
A 2-Part Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee ReplacementEUCTR2016-004550-15-ROJanssen-Cilag International NV305
进行中（未招募）
1 期
A 2-Part Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee ReplacementEUCTR2016-004550-15-PLJanssen-Cilag International NV1,500