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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Thrombosis, Venous Thrombosis

Intervention / Treatment
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* Drug: Alfimeprase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alfimeprase|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter function restoration at fifteen minutes after initial instillation of study drug. |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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occluded central catheter, central venous access devices dysfunction, withdrawal occlusion, Thrombosis, Venous thrombosis