PHASE 3, MULTICENTER, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALFIMEPRASE IN SUBJECTS WITH OCCLUDED CENTRAL VENOUS ACCESS DEVICES

• Conditions: Central venous access device occlusion

• Registration Number: EUCTR2005-003282-16-BE
• Lead Sponsor: uvelo, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Subjects who meet all of the following criteria will be eligible for enrollment:
a) The subject (or legally acceptable representative) must give written informed consent
b) Unable to withdraw 3 mL of blood from a central venous access device
c) Hemodynamically stable
d) 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) Evidence of mechanical or nonthrombotic occlusion
f) Receipt of any thrombolytic agent within 24 hours of randomization
g) 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
h) Increased risk for drug extravasation
i) Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator).
j) Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
k) Participation in any other study of an investigational device, medication, biologic, or other agent within the 30 days before enrollment and until the 30-day follow up visit
l) 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