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

Primary Purpose

Thrombosis, Venous Thrombosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alfimeprase
Sponsored by
ARCA Biopharma, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis focused on measuring occluded central catheter, central venous access devices dysfunction, withdrawal occlusion, Thrombosis, Venous thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Corvallis Clinic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 28, 2006
Last Updated
August 12, 2008
Sponsor
ARCA Biopharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00346424
Brief Title
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
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 Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ARCA Biopharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Venous Thrombosis
Keywords
occluded central catheter, central venous access devices dysfunction, withdrawal occlusion, Thrombosis, Venous thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alfimeprase
Primary Outcome Measure Information:
Title
Catheter function restoration at fifteen minutes after initial instillation of study drug.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Catheter function restoration at 30 minutes after initial instillation of study drug.
Time Frame
30 minutes
Title
Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose.
Time Frame
additional 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Deitcher, M.D.
Organizational Affiliation
ARCA Biopharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Corvallis Clinic
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States

12. IPD Sharing Statement

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

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