Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00322270
• Date of registration: 03/05/2006
• Primary sponsor: ARCA Biopharma, Inc.
• Public title: Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
• Scientific title: Phase 3, Multicenter, Multinational, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects With Occluded Central Venous Access Devices (SONOMA-3)
• Date of first enrolment: January 2006
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00322270
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Susan Begelman, M.D.
• Affiliation: ARCA Biopharma, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Catheter Occlusion

Thrombosis

Venous Thrombosis

Intervention(s)

Drug: Alfimeprase

Primary Outcome(s)

Safety and efficacy [Time Frame: up to120 minutes post study drug dosing]

Secondary Outcome(s)

Adverse events up to day 30 visit(day 28-45) after instillation of study drug [Time Frame: approximately 28-45 days post dosing]

Adverse events, serious adverse events and bleeding events [Time Frame: 24 hours post dosing]

Secondary ID(s)

HA008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors