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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
N/A
Not Enrolling
Both
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
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

Type of Study:

Interventional

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.

Authority:

United States: Food and Drug Administration

Study ID:

HA008

NCT ID:

NCT00322270

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

Name

Location

Texas Oncology, P.A.Dallas, Texas  75246
Dakota Cancer InstituteFargo, North Dakota  58103-4940
Mercy HospitalMiami, Florida  33133
Gabrail Cancer CenterCanton, Ohio  44718
Pasco Hernando Oncology AssociatesNew Port Richey, Florida  34652
Medical and Surgical SpecialistsGalesburg, Illinois  61401
Desert Oasis Cancer CenterCasa Grande, Arizona  85222
Cancer Research & Prevention CenterSoquel, California  95073
Kalamazoo Hematology and OncologyKalamazoo, Michigan  49048
The Center for Cancer Care and ResearchSt. Louis, Missouri  63141
Bethesda Research CenterBoynton Beach, Florida  33435
Pasco Hernando Oncology AssociateNew Port Richey, Florida  34652
Cancer Center at Blessing HospitalQuincy, Illinois  62301
Sparrow Cancer CenterLansing, Michigan  48912
Comprehensive Cancer Care ClinicJefferson City, Missouri  65109
UMDNJ-Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Hematology/Oncology Consultants, Inc.Columbus, Ohio  43235
Carilion Gynecology/OncologyRoanoke, Virginia  24074