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

ARCA Biopharma

Status and phase

Completed

Phase 3

Conditions

Thrombosis

Venous Thrombosis

Treatments

Drug: Alfimeprase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00346424

HA006

Details and patient eligibility

About

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

Full 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.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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