Thrombosis Clinical Trial
Official 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)
NCT number | NCT00322270 |
Other study ID # | HA008 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | May 3, 2006 |
Last updated | August 12, 2008 |
Start date | January 2006 |
Verified date | August 2008 |
Source | ARCA Biopharma, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Bethesda Research Center | Boynton Beach | Florida |
United States | Pasco Hernando Oncology Associates | Brooksville | Florida |
United States | Gabrail Cancer Center | Canton | Ohio |
United States | Desert Oasis Cancer Center | Casa Grande | Arizona |
United States | Hematology/Oncology Consultants, Inc. | Columbus | Ohio |
United States | Texas Oncology, P.A. | Dallas | Texas |
United States | Dakota Cancer Institute | Fargo | North Dakota |
United States | Medical and Surgical Specialists | Galesburg | Illinois |
United States | Comprehensive Cancer Care Clinic | Jefferson City | Missouri |
United States | Kalamazoo Hematology and Oncology | Kalamazoo | Michigan |
United States | Sparrow Cancer Center | Lansing | Michigan |
United States | Mercy Hospital | Miami | Florida |
United States | UMDNJ-Robert Wood Johnson Medical School | New Brunswick | New Jersey |
United States | Pasco Hernando Oncology Associate | New Port Richey | Florida |
United States | Cancer Center at Blessing Hospital | Quincy | Illinois |
United States | Carilion Gynecology/Oncology | Roanoke | Virginia |
United States | Cancer Research & Prevention Center | Soquel | California |
United States | The Center for Cancer Care and Research | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
ARCA Biopharma, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and efficacy | up to120 minutes post study drug dosing | ||
Secondary | Adverse events, serious adverse events and bleeding events | 24 hours post dosing | ||
Secondary | Adverse events up to day 30 visit(day 28-45) after instillation of study drug | approximately 28-45 days post dosing |
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