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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)

Phase 3
18 Years
Not Enrolling
Thrombosis, Venous Thrombosis, Catheter Occlusion

Thank you

Trial Information

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)

Further study details as provided by Nuvelo

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and efficacy

Outcome Time Frame:

up to120 minutes post study drug dosing

Principal Investigator

Susan Begelman, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

ARCA Biopharma, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Thrombosis
  • Venous Thrombosis
  • Catheter Occlusion
  • Occluded Central Venous Access Devices
  • Occluded Catheters
  • Thrombosis
  • thrombosis, catheter
  • alfimeprase
  • thrombotic occlusion
  • thrombosis, CVAD
  • thrombosis, catheters
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism



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