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Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

Primary Purpose

Thrombosis, Venous Thrombosis, Catheter Occlusion

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 Venous Access Devices, Occluded Catheters, Thrombosis, thrombosis, catheter, alfimeprase, thrombotic occlusion, thrombosis, CVAD, thrombosis, catheters

Eligibility Criteria

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

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

Sites / Locations

  • Desert Oasis Cancer Center
  • Cancer Research & Prevention Center
  • Bethesda Research Center
  • Pasco Hernando Oncology Associates
  • Mercy Hospital
  • Pasco Hernando Oncology Associate
  • Medical and Surgical Specialists
  • Cancer Center at Blessing Hospital
  • Kalamazoo Hematology and Oncology
  • Sparrow Cancer Center
  • Comprehensive Cancer Care Clinic
  • The Center for Cancer Care and Research
  • UMDNJ-Robert Wood Johnson Medical School
  • Dakota Cancer Institute
  • Gabrail Cancer Center
  • Hematology/Oncology Consultants, Inc.
  • Texas Oncology, P.A.
  • Carilion Gynecology/Oncology

Outcomes

Primary Outcome Measures

Safety and efficacy

Secondary Outcome Measures

Adverse events, serious adverse events and bleeding events
Adverse events up to day 30 visit(day 28-45) after instillation of study drug

Full Information

First Posted
May 3, 2006
Last Updated
August 12, 2008
Sponsor
ARCA Biopharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00322270
Brief Title
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ARCA Biopharma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Further study details as provided by Nuvelo

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Venous Thrombosis, Catheter Occlusion
Keywords
Occluded Central Venous Access Devices, Occluded Catheters, Thrombosis, thrombosis, catheter, alfimeprase, thrombotic occlusion, thrombosis, CVAD, thrombosis, catheters

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alfimeprase
Intervention Description
single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
Primary Outcome Measure Information:
Title
Safety and efficacy
Time Frame
up to120 minutes post study drug dosing
Secondary Outcome Measure Information:
Title
Adverse events, serious adverse events and bleeding events
Time Frame
24 hours post dosing
Title
Adverse events up to day 30 visit(day 28-45) after instillation of study drug
Time Frame
approximately 28-45 days post dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Begelman, M.D.
Organizational Affiliation
ARCA Biopharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Desert Oasis Cancer Center
City
Casa Grande
State/Province
Arizona
ZIP/Postal Code
85222
Country
United States
Facility Name
Cancer Research & Prevention Center
City
Soquel
State/Province
California
ZIP/Postal Code
95073
Country
United States
Facility Name
Bethesda Research Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Pasco Hernando Oncology Associates
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Mercy Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Pasco Hernando Oncology Associate
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Medical and Surgical Specialists
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Cancer Center at Blessing Hospital
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Kalamazoo Hematology and Oncology
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Sparrow Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Comprehensive Cancer Care Clinic
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
The Center for Cancer Care and Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
UMDNJ-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Dakota Cancer Institute
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Hematology/Oncology Consultants, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Texas Oncology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Carilion Gynecology/Oncology
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24074
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

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