Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

Thrombosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322270
• Other study ID #: HA008
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2006
• Last updated: August 12, 2008
• Start date: January 2006

Study information

• Verified date: August 2008
• Source: ARCA Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Further study details as provided by Nuvelo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheter Occlusion
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Alfimeprase
single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD

Locations

Country	Name	City	State
United States	Bethesda Research Center	Boynton Beach	Florida
United States	Pasco Hernando Oncology Associates	Brooksville	Florida
United States	Gabrail Cancer Center	Canton	Ohio
United States	Desert Oasis Cancer Center	Casa Grande	Arizona
United States	Hematology/Oncology Consultants, Inc.	Columbus	Ohio
United States	Texas Oncology, P.A.	Dallas	Texas
United States	Dakota Cancer Institute	Fargo	North Dakota
United States	Medical and Surgical Specialists	Galesburg	Illinois
United States	Comprehensive Cancer Care Clinic	Jefferson City	Missouri
United States	Kalamazoo Hematology and Oncology	Kalamazoo	Michigan
United States	Sparrow Cancer Center	Lansing	Michigan
United States	Mercy Hospital	Miami	Florida
United States	UMDNJ-Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Pasco Hernando Oncology Associate	New Port Richey	Florida
United States	Cancer Center at Blessing Hospital	Quincy	Illinois
United States	Carilion Gynecology/Oncology	Roanoke	Virginia
United States	Cancer Research & Prevention Center	Soquel	California
United States	The Center for Cancer Care and Research	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
ARCA Biopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy		up to120 minutes post study drug dosing
Secondary	Adverse events, serious adverse events and bleeding events		24 hours post dosing
Secondary	Adverse events up to day 30 visit(day 28-45) after instillation of study drug		approximately 28-45 days post dosing