Clinical trial NCT00322270: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thrombosis
Venous Thrombosis
Catheter Occlusion
Keywords: Occluded Central Venous Access Devices
Occluded Catheters
Thrombosis
thrombosis, catheter
alfimeprase
thrombotic occlusion
thrombosis, CVAD
thrombosis, catheters
Lead sponsor: ARCA Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Safety and efficacy
timeFrame: up to120 minutes post study drug dosing
Secondary outcomes:
measure: Adverse events, serious adverse events and bleeding events
timeFrame: 24 hours post dosing
measure: Adverse events up to day 30 visit(day 28-45) after instillation of study drug
timeFrame: approximately 28-45 days post dosing
Other outcomes:
Locations:
city: Casa Grande
country: United States
facility: Desert Oasis Cancer Center
state: Arizona
city: Soquel
country: United States
facility: Cancer Research & Prevention Center
state: California
city: Boynton Beach
country: United States
facility: Bethesda Research Center
state: Florida
city: Brooksville
country: United States
facility: Pasco Hernando Oncology Associates
state: Florida
city: Miami
country: United States
facility: Mercy Hospital
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology Associate
state: Florida
city: Galesburg
country: United States
facility: Medical and Surgical Specialists
state: Illinois
city: Quincy
country: United States
facility: Cancer Center at Blessing Hospital
state: Illinois
city: Kalamazoo
country: United States
facility: Kalamazoo Hematology and Oncology
state: Michigan
city: Lansing
country: United States
facility: Sparrow Cancer Center
state: Michigan
city: Jefferson City
country: United States
facility: Comprehensive Cancer Care Clinic
state: Missouri
city: St. Louis
country: United States
facility: The Center for Cancer Care and Research
state: Missouri
city: New Brunswick
country: United States
facility: UMDNJ-Robert Wood Johnson Medical School
state: New Jersey
city: Fargo
country: United States
facility: Dakota Cancer Institute
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Hematology/Oncology Consultants, Inc.
state: Ohio
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Roanoke
country: United States
facility: Carilion Gynecology/Oncology
state: Virginia
Study officials:
affiliation: ARCA Biopharma, Inc.
name: Susan Begelman, M.D.
role: STUDY_DIRECTOR
References: