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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of alfimeprase.;Secondary Objective: To evaluate the efficacy of alfimeprase as measured by:<br><br>1. The proportion of subjects with re-establishment of a functional CVAD 15 minutes following the initial instillation of study drug.<br>2. The proportion of subjects with re-establishment of a functional CVAD 30 minutes following the initial instillation of study drug.<br>3. The proportion of subjects with re-establishment of a functional CVAD 30 minutes following the instillation of one or two doses of study drug.;Primary end point(s): The rates of adverse events, serious adverse events and major bleeding events during the time from initial instillation of study drug until up to 120 minutes following the final instillation of study drug.

Secondary Outcome Measures

Name	Time	Method

Related Trials