Phase II, Open-Label Study in the Catheterization Laboratory Setting to Challenge the Concept That HBOC-201 Administration Might Improve Myocardial 'Oxygenation' and Myocardial Function at the Moment of (Brief) Coronary Occlusion
Sponsor study identifier
interventional
5
1 country
1
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
April 2008
Actual (reported)The test compound and subject of this clinical trial is the haemoglobin-based oxygen carrier, HBOC-201 (Hemopure). HBOC-201, initially developed as an alternative to red blood cells for surgical patients, has the ability to restore tissue oxygenation in persistently ischemic tissue. The development of this new class of compounds, referred to as oxygen therapeutics, provides an opportunity to test the safety and efficacy of a new approach to management of myocardial ischemia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 25, 2007
Actual (reported)May 28, 2007
Actual (reported)March 2008
Actual (reported)April 2008
Actual (reported)To study the change in left ventricular relaxation indices and pressure-half time and the change in the sum of ST segment deviations compared to baseline.
Duration of the study
LV hemodynamics; change of ST segment; QCA analysis before and after the no-infusion control occlusion and HBOC-201 infusion/occlusion; safety endpoints
Duration of the study
Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion
Dry occlusion followed by occlusion with pre-oxygenated HBOC-201
Pre-oxygenated HBOC-201
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Thoraxcentre - Erasmus MC
Rotterdam, Netherlands
A. Gerson Greenburg, MD, PhD
Biopure Corporation
5 participants (actual enrollment reported by the registry).
First Submitted
May 25, 2007
First Posted
May 28, 2007
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2008
Actual (reported)Study Completion
April 2008
Actual (reported)Last Updated
May 30, 2008
Record last verified: 2008-05
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Source: ClinicalTrials.gov.
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