Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

ARCA Biopharma

Status and phase

Completed

Phase 3

Conditions

Catheter Occlusion

Thrombosis

Venous Thrombosis

Treatments

Drug: Alfimeprase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00322270

HA008

Details and patient eligibility

About

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.

Full description

Further study details as provided by Nuvelo

Sex

All

Ages

18+ years old

Volunteers

No 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