Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters

Sponsor

ARCA Biopharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00346424

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.

Condition or Disease	Intervention/Treatment	Phase
Thrombosis Venous Thrombosis	Drug: Alfimeprase	Phase 3

Detailed Description

Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug.

Secondary Outcomes:

The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation.

Safety:

Adverse events
Major bleeding events
Change in laboratory values.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Catheter function restoration at fifteen minutes after initial instillation of study drug. [15 minutes]

Secondary Outcome Measures

Catheter function restoration at 30 minutes after initial instillation of study drug. [30 minutes]
Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose. [additional 30 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must give written informed consent
Unable to withdraw 3 mL of blood from a central venous access device
Hemodynamically stable
Available for follow-up assessments

Exclusion Criteria:

Inability to infuse at least 2 mL of saline through the catheter
Catheter placed less than 48 hours prior to detection of occlusion
Catheter used for hemodialysis of pheresis
Less than 18 years of age
Evidence of mechanical or nonthrombotic occlusion
Receipt of any thrombolytic agent within 24 hours of randomization
In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
Increased risk for drug extravasation
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)
Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
Any other subject feature that in the opinion of the investigator should preclude study participation