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US Navy submits protocol to FDA for field trauma trial of Hemopure
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Biopure
: 23 June, 2008 (Company News) |
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Biopure has announced the US Naval Medical Research Center (NMRC) has submitted a new protocol for review by the Food and Drug Administration (FDA) for a Phase 2 clinical trial of Hemopure [haemoglobin glutamer - 250 (bovine)], or HBOC-201, for resuscitation of operational casualties with severe traumatic haemorrhagic shock without availability of blood transfusions. |
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The proposed trial hypotheses is that for such casualties Hemopure will improve survival and other clinical parameters, and will be relatively safe and well tolerated, in comparison with ‘standard fluid’. Subjects will sign an informed consent prospectively. The study is entitled ‘Operational Restore Effective Survival in Shock (Op RESUS)’.
Op RESUS is designed as a single-blinded, randomized and controlled trial with up to 340 evaluable subjects, including operational military and civilian personnel (Department of Defense health system eligible). The primary aim of the study is to compare the 28-day relative rate of death in patients receiving Hemopure versus the group of patients receiving the ‘standard fluid’ for resuscitation (Hextend). Secondary and tertiary outcome measures are also defined. All subjects would receive blood transfusions, when indicated, upon availability.
A successful completion, if attained, of Op RESUS safety primary objectives is expected to support an application to the FDA for allowance to conduct a definitive Phase 3 trial and have potential to improve survival of haemorrhagic shock casualties.
Under a research agreement with Biopure, the NMRC has had primary responsibility for designing, seeking FDA acceptance of and directing a pivotal trauma trial. In carrying out that agreement, the Navy designed and submitted to the FDA a proposed phase 2/3 trial entitled ‘Restore Effective Survival in Shock’ (RESUS). That trial would have been conducted prehospital in civilian trauma patients.
The trial was placed on clinical hold by the FDA and continues to be on hold following changes intended to address FDA comments. The newly filed protocol, by incorporating informed consent, is intended to remove requirements attendant to waiver of informed consent. To date, the US Congress has appropriated a total of $24.2 million for the development of Hemopure.
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