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) - ND

• Conditions: Central venous access device withdrawal occlusion; MedDRA version: 9.1Level: SOCClassification code 10042613Term: Surgical and medical procedures

• Registration Number: EUCTR2006-000545-19-IT
• Lead Sponsor: VELO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

a) The subject (or legally authorized representative) must give written informed consent;

b) Unable to withdraw 3mL of blood from a central venous access device;

c) If previously with CathfloActivase, 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

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 eventus or embolic complications, or has a condition for which bleeding constitutes a significatn 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 invetigator);

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: 1. the proportion of subjects with re-establishment of a functional CVAD 15 minutes following the initial instillation of study drug; 2. the proportion of subjects with re-establishment of a funcional CVAD 30 minutes following the initial instillation of study drug; 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 dime from initial instillation of study drug until up to 120 minutes following the final instillation of study drug.