Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317512
Status:
COMPLETED
Last Update Posted:
2008-05-16
First Post:
2006-04-21
Brief Title:
Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
Sponsor:
Biopure Corporation
Organization:
Biopure Corporation
Study Overview
Official Title:
A Multi-CenterRandomizedDouble-BlindPlacebo-ControlledDose Finding Pilot Study to Evaluate SafetyFeasibility of HBOC-201 in Elective Percutaneous Coronary Revascularization of Subjects With Acute Coronary Syndromes
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and feasibility of a novel oxygen carrying solution HBOC-201 in the setting of PCI for Acute Coronary Syndromes from randomization til hospital discharge
Detailed Description:
Acute coronary syndromes are due to an acute or subacute primary reduction of myocardial oxygen supply provoked by disruption of an atherosclerotic plaque associated with inflammation thrombosis vasoconstriction and microembolization Occlusive thrombosis superimposed on a ruptured atheroma in an epicardial coronary artery is firmly established as the immediate cause of an acute ST-segment Elevation Myocardial Infarction STEMI Rapid restoration of blood flow oxygen supply to jeopardized myocardium limits necrosis and reduces mortality This can be accomplished medically with a thrombolytic agent or mechanically with so-called primary balloon angioplasty or stenting Primary percutaneous coronary intervention PCI has become the preferred therapy for STEMI in most developed countries
HBOC-201 is a solution belonging to a new class of biologic oxygen therapeutics hemoglobin based oxygen carriers HBOC-201 is a crosslinked and glutaraldehyde-polymerized hemoglobin Hb extracted from isolated bovine red blood cells On a gram-for-gram basis HBOC-201 was calculated to be approximately three times more potent than stored fresh red blood cell hemoglobin at restoring baseline tissue oxygenation following severe acute anemia Evaluation of this Hemoglobin Based Oxygen Carrier has been undertaken in 57 preclinical studies and 21 human clinical trials The compound is under review by the US FDA and has been approved in the Republic of South Africa However HBOC-201 has not yet been evaluated in the setting of this disease narrowing of a coronary artery
Biopure will be studying the safety and feasibility of HBOC-201 in patients with typical symptoms of Unstable Angina or Non ST-segment Elevation Myocardial Infarction eligible to undergo invasive revascularization through a PCI procedure
HBOC-201 is a solution belonging to a new class of biologic oxygen therapeutics hemoglobin based oxygen carriers HBOC-201 is a crosslinked and glutaraldehyde-polymerized hemoglobin Hb extracted from isolated bovine red blood cells On a gram-for-gram basis HBOC-201 was calculated to be approximately three times more potent than stored fresh red blood cell hemoglobin at restoring baseline tissue oxygenation following severe acute anemia Evaluation of this Hemoglobin Based Oxygen Carrier has been undertaken in 57 preclinical studies and 21 human clinical trials The compound is under review by the US FDA and has been approved in the Republic of South Africa However HBOC-201 has not yet been evaluated in the setting of this disease narrowing of a coronary artery
Biopure will be studying the safety and feasibility of HBOC-201 in patients with typical symptoms of Unstable Angina or Non ST-segment Elevation Myocardial Infarction eligible to undergo invasive revascularization through a PCI procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None