Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
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
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2005
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 28, 2006
CompletedFirst Posted
Study publicly available on registry
June 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedAugust 14, 2008
August 1, 2008
1.1 years
June 28, 2006
August 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Catheter function restoration at fifteen minutes after initial instillation of study drug.
15 minutes
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Corvallis Clinic
Corvallis, Oregon, 97330, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steven Deitcher, M.D.
ARCA Biopharma, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 28, 2006
First Posted
June 30, 2006
Study Start
September 1, 2005
Primary Completion
October 1, 2006
Study Completion
December 1, 2006
Last Updated
August 14, 2008
Record last verified: 2008-08