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Trial Information
Summary: 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)
Nuvelo, Inc. is conducting a clinical trial to study the safety
and efficacy of alfimeprase (study drug) in subjects with occluded
(blocked) central venous access devices.
Study drug and study procedures will be made available to you at
no cost.
To qualify you must:
- Be at least 18 years old
- Have an occluded (blocked) central venous access device (unable
to withdraw 3 mL of blood from the catheter)
- Be willing to return for follow-up assessments
You will not qualify if:
- Pregnant or breast-feeding
- The study doctor or study nurse is unable to infuse at least 2
mL of saline through the catheter
- The study doctor or study nurse is able to withdraw 3 mL of
blood from a central venous access device
- The catheter was placed less than 48 hours prior to detection
of the occlusion
- Confirmed mechanical or non-thrombotic occlusion of
catheter
- The study doctor feels you are at a high risk for bleeding
events
- Have certain heart conditions (right-to-left cardiac shunt,
patent foramen ovale, or atrial/ventricular septal defect)
- Unable to use adequate method of contraception during the study
period
- Have received an investigational agent within 30 days of the
start of the study
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Contact:
Dominik Verdier-Pinard, Study Coordinator
Biomedical Research Alliance of New York
Montefiore Medical Center
111 East 210th Street
Bronx, NY 10467
Telephone: 718-920-2090
Email:
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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Trial listings updated: June 1, 2008 at 5:45:50 AM
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