Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters - Full Text View

Sponsored by:	Nuvelo
Information provided by:	Nuvelo
ClinicalTrials.gov Identifier:	NCT00346424

Purpose

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

Condition	Intervention	Phase
Thrombosis Venous Thrombosis	Drug: Alfimeprase	Phase III

MedlinePlus related topics: Deep Vein Thrombosis

Drug Information available for: Alfimeprase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Nuvelo:

Primary Outcome Measures:

Catheter function restoration at fifteen minutes after initial instillation of study drug. [ Time Frame: 15 minutes ]

Secondary Outcome Measures:

Catheter function restoration at 30 minutes after initial instillation of study drug. [ Time Frame: 30 minutes ]
Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose. [ Time Frame: additional 30 minutes ]

Enrollment:	300
Study Start Date:	September 2005
Study Completion Date:	December 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346424

Locations

United States, Oregon
Corvallis Clinic
Corvallis, Oregon, United States, 97330

Sponsors and Collaborators

Nuvelo

Investigators

Study Director:

Steven Deitcher, M.D.

Nuvelo

More Information

Study ID Numbers:	HA006
Study First Received:	June 28, 2006
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00346424
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nuvelo:

occluded central catheter
central venous access devices dysfunction
withdrawal occlusion
Thrombosis
Venous thrombosis

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Venous Thrombosis
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009