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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial 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.


Description:

Further study details as provided by Nuvelo


Recruitment information / eligibility

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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Alfimeprase
single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
ARCA Biopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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