Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

Sponsor

ARCA Biopharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00322270

Collaborator

(none)

Locations

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thrombosis Venous Thrombosis Catheter Occlusion	Drug: Alfimeprase	Phase 3

Detailed Description

Further study details as provided by Nuvelo

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Safety and efficacy [up to120 minutes post study drug dosing]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Desert Oasis Cancer Center	Casa Grande	Arizona	United States	85222
2	Cancer Research & Prevention Center	Soquel	California	United States	95073
3	Bethesda Research Center	Boynton Beach	Florida	United States	33435
4	Pasco Hernando Oncology Associates	Brooksville	Florida	United States	34613
5	Mercy Hospital	Miami	Florida	United States	33133
6	Pasco Hernando Oncology Associate	New Port Richey	Florida	United States	34652
7	Medical and Surgical Specialists	Galesburg	Illinois	United States	61401
8	Cancer Center at Blessing Hospital	Quincy	Illinois	United States	62301
9	Kalamazoo Hematology and Oncology	Kalamazoo	Michigan	United States	49048
10	Sparrow Cancer Center	Lansing	Michigan	United States	48912
11	Comprehensive Cancer Care Clinic	Jefferson City	Missouri	United States	65109
12	The Center for Cancer Care and Research	St. Louis	Missouri	United States	63141
13	UMDNJ-Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
14	Dakota Cancer Institute	Fargo	North Dakota	United States	58103
15	Gabrail Cancer Center	Canton	Ohio	United States	44718
16	Hematology/Oncology Consultants, Inc.	Columbus	Ohio	United States	43235
17	Texas Oncology, P.A.	Dallas	Texas	United States	75230
18	Carilion Gynecology/Oncology	Roanoke	Virginia	United States	24074