Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters

Thrombosis Clinical Trial

Official title:

Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Occluded Central Venous Access Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346424
• Other study ID #: HA006
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2006
• Last updated: August 12, 2008
• Start date: September 2005
• Est. completion date: December 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

The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.

Description:

Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug.

Secondary Outcomes:

The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation.

Safety:

• Adverse events

• Major bleeding events

• Change in laboratory values.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must give written informed consent

• Unable to withdraw 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 of pheresis

• Less than 18 years of age

• Evidence of mechanical or nonthrombotic occlusion

• Receipt of any thrombolytic agent within 24 hours of randomization

• 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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Alfimeprase

Locations

Country	Name	City	State
United States	Corvallis Clinic	Corvallis	Oregon

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	Catheter function restoration at fifteen minutes after initial instillation of study drug.		15 minutes
Secondary	Catheter function restoration at 30 minutes after initial instillation of study drug.		30 minutes
Secondary	Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose.		additional 30 minutes