Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

Study Overview
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Brief Summary
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To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device.

Detailed Description
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Further study details as provided by Nuvelo

Official Title
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Phase 3, Multicenter, Multinational, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects With Occluded Central Venous Access Devices (SONOMA-3)

Conditions
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Thrombosis, Venous Thrombosis, Catheter Occlusion

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 Ages 18 or older Unable to withdraw at least 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 or pheresis Previous treatment with plasminogen activator for current episode of catheter occlusion Less than 18 years of age Any evidence of mechanical or nonthrombotic occlusion 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alfimeprase|single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy |  | up to120 minutes post study drug dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, serious adverse events and bleeding events |  | 24 hours post dosing | 
| Adverse events up to day 30 visit(day 28-45) after instillation of study drug |  | approximately 28-45 days post dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occluded Central Venous Access Devices, Occluded Catheters, Thrombosis, thrombosis, catheter, alfimeprase, thrombotic occlusion, thrombosis, CVAD, thrombosis, catheters