Overview

Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ARCA Biopharma, Inc.
Criteria
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