NCT00479895

Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Biopure Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Because of their ability to perfuse and deliver oxygen, hemoglobin-based oxygen carriers (HBOC) may be considered in the treatment of several ischemic conditions, such as acute coronary syndromes (ACS). Elective percutaneous intervention (PCI) induces transient myocardial ischemia due to reduction of coronary flow during balloon inflation in the coronary artery, thus simulating in a control setting, the occurrence of an ACS.

Conditions

• Coronary Occlusion
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)	Pre-oxygenated HBOC-201

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-03-01
• Completion: 2008-04-01
• First posted: 2007-05-28
• Last updated: 2008-05-30

Locations

1 site across 1 country: Netherlands