Phase 3, Multicenter, Multi-National, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects with Occluded Central Venous Access Devices - SONOMA-3

uvelo, Inc.0 个研究点目标入组 800 人开始时间: 2006年6月2日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Subjects who meet all of the following criteria will be eligible for enrollment.
•a) The subject (or legally authorized representative) must give written informed consent.
•b) Unable to withdraw 3 mL of blood from a central venous access device.
•c) If previously with Cathflo® Activase®, at least 2 hours has elapsed since the
•instillation of the last dose of Cathflo® Activase®.
•d) Hemodynamically stable
•e) Available for follow-up assessments
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Subjects who meet any of the following criteria are not eligible for enrollment.
•a) Inability to infuse at least 2 mL of saline through the catheter
•b) Catheter placed < 48 hours prior to detection of occlusion
•c) Catheter used for hemodialysis or pheresis
•d) < 18 years of age
•e) Confirmed mechanical or nonthrombotic occlusion
•f) In the opinion of the investigator, subject is at high risk” for bleeding events or embolic complications, or has a condition for which bleeding constitutes a significant hazard
•g) Increased risk of drug extravasation
•h) Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using active contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraceptive deemed adequate by the investigator)
•i) Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
•j) Participation in any other study of an investigational device, medication, biologic, or other agent within the 30 days before enrollment and until the 30 days before enrollment and until the 30-day follow up visit
•k) Any other subject feature that in the opinion of the investigator should preclude study participation

发起方

uvelo, Inc.